TriangleNCT04299425 · STUDY IN CONTEXT
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month.
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- trial label
- Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0000
- source section id
- NCT04299425-om-0000
- source outcome index
- 0
- endpoint
- Average Number of Parathyroid Glands Identified With High Confidence Per Patient
- endpoint definition
- Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
- time origin
- Immediate. During PTx procedure.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0001
- source section id
- NCT04299425-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
- endpoint definition
- If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month.
- time origin
- 6 months after PTx procedure
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0002
- source section id
- NCT04299425-om-0002
- source outcome index
- 2
- endpoint
- Number of Frozen Sections Sent for Analysis
- endpoint definition
- Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
- time origin
- Immediate. During PTx procedure.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0003
- source section id
- NCT04299425-om-0003
- source outcome index
- 3
- endpoint
- Duration of Parathyroidectomy (PTx) Procedure
- endpoint definition
- Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
- time origin
- Immediate. During PTx procedure.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0004
- source section id
- NCT04299425-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants Stratified by Duration of Hospital Stay
- endpoint definition
- Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
- time origin
- 0-72 hours after PTx procedure.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0005
- source section id
- NCT04299425-om-0005
- source outcome index
- 5
- endpoint
- Number of 'False Positive' Tissues Excised by Surgeon
- endpoint definition
- Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
- time origin
- Immediate to 10 days after PTx procedure.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only the NIRAF Detection Technology + arm was included in the analysis to calculate the rate of false positives by the device. Since the NIRAF Detection Technology - did not use the device that arm was not included.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0000
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0000
- arm key
- OG001
- arm label
- NIRAF Detection Technology -
- regimen
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0001
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0001
- arm key
- OG001
- arm label
- NIRAF Detection Technology -
- regimen
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0002
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0002
- arm key
- OG001
- arm label
- NIRAF Detection Technology -
- regimen
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0003
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0003
- arm key
- OG001
- arm label
- NIRAF Detection Technology -
- regimen
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0004
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0004
- arm key
- OG001
- arm label
- NIRAF Detection Technology -
- regimen
- Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- outcome key
- om-0005
- arm key
- OG000
- arm label
- NIRAF Detection Technology +
- regimen
- Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04299425-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- harm key
- EG000
- source section id
- NCT04299425-ae
- event group key
- EG000
- event group label
- NIRAF Detection Technology +
- serious affected
- 0
- serious at risk
- 80
- other affected
- 0
- other at risk
- 80
- frequency threshold
- 0
- collection period
- Adverse event data was collected for 2 years, 5 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT04299425
- harm key
- EG001
- source section id
- NCT04299425-ae
- event group key
- EG001
- event group label
- NIRAF Detection Technology -
- serious affected
- 0
- serious at risk
- 80
- other affected
- 0
- other at risk
- 80
- frequency threshold
- 0
- collection period
- Adverse event data was collected for 2 years, 5 months.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice