TriangleNCT05022667 · STUDY IN CONTEXT
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
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
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Blood parathyroid hormone (PTH) levels at 5-14 days post-op
Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
Blood calcium levels 24-48 hours after surgery
Duration of surgery (minutes)
Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
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-endocrine-carcinoma
- nct id
- NCT05022667
- trial label
- Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0000
- source section id
- NCT05022667-om-0000
- source outcome index
- 0
- endpoint
- The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
- endpoint definition
- Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
- time origin
- Immediate (During total thyroidectomy 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0001
- source section id
- NCT05022667-om-0001
- source outcome index
- 1
- endpoint
- Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery
- endpoint definition
- Blood parathyroid hormone (PTH) levels at 5-14 days post-op
- time origin
- 5-14 days after surgery
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not all participants returned for this lab assessment during the 5-14 day data collection period. As such, no data for these participants was collected.
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0002
- source section id
- NCT05022667-om-0002
- source outcome index
- 2
- endpoint
- Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery
- endpoint definition
- Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
- time origin
- Within 24-48 hours after surgery
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0003
- source section id
- NCT05022667-om-0003
- source outcome index
- 3
- endpoint
- Blood Calcium Levels 24-48 Hours After Surgery
- endpoint definition
- Blood calcium levels 24-48 hours after surgery
- time origin
- Within 24-48 hours after surgery
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0004
- source section id
- NCT05022667-om-0004
- source outcome index
- 4
- endpoint
- Duration in Minutes of Surgery
- endpoint definition
- Duration of surgery (minutes)
- time origin
- Collected immediately following surgery
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0005
- source section id
- NCT05022667-om-0005
- source outcome index
- 5
- endpoint
- Number of Frozen Section Analysis Performed.
- endpoint definition
- Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
- time origin
- Collected immediately following surgery
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0000
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0001
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0002
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 56
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0003
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 54
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0004
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0005
- arm key
- OG000
- arm label
- PTeye
- regimen
- The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure. PTeye: The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 57
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022667-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05022667
- harm key
- EG000
- source section id
- NCT05022667-ae
- event group key
- EG000
- event group label
- PTeye
- serious affected
- 0
- serious at risk
- 57
- other affected
- 0
- other at risk
- 57
- frequency threshold
- 0
- collection period
- Adverse event data was collected up to 6-months after surgery.
- 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-endocrine-carcinoma
- nct id
- NCT05022667
- harm key
- EG001
- source section id
- NCT05022667-ae
- event group key
- EG001
- event group label
- Standard of Care
- serious affected
- 0
- serious at risk
- 57
- other affected
- 0
- other at risk
- 57
- frequency threshold
- 0
- collection period
- Adverse event data was collected up to 6-months after surgery.
- 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