TriangleNCT05022641 · STUDY IN CONTEXT
Evaluating Impact of Near Infrared Autofluorescence (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 between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
\>50% drop from baseline at 10 minutes post-resection
Surgery duration in minutes
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants 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-parathyroid-cancer
- nct id
- NCT05022641
- trial label
- Evaluating Impact of Near Infrared Autofluorescence (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
- NCT05022641
- outcome key
- om-0000
- source section id
- NCT05022641-om-0000
- source outcome index
- 0
- endpoint
- Average Number of Parathyroid Glands Identified
- endpoint definition
- Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.
- time origin
- Measured within the procedure, generally not more than 2 hours
- 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
- NCT05022641
- outcome key
- om-0001
- source section id
- NCT05022641-om-0001
- source outcome index
- 1
- endpoint
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery
- endpoint definition
- Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
- 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-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0002
- source section id
- NCT05022641-om-0002
- source outcome index
- 2
- endpoint
- Appropriate Intraoperative Parathyroid Hormone Drop
- endpoint definition
- \>50% drop from baseline at 10 minutes post-resection
- time origin
- baseline to 10 minutes
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame.
- 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
- NCT05022641
- outcome key
- om-0003
- source section id
- NCT05022641-om-0003
- source outcome index
- 3
- endpoint
- Duration of Surgery
- endpoint definition
- Surgery duration in minutes
- time origin
- Measured within the procedure, generally not more than 2 hours
- 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
- NCT05022641
- outcome key
- om-0004
- source section id
- NCT05022641-om-0004
- source outcome index
- 4
- endpoint
- Number of Nights Spent in the Hospital After Parathyroidectomy
- 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
- NCT05022641
- outcome key
- om-0005
- source section id
- NCT05022641-om-0005
- source outcome index
- 5
- endpoint
- Number of Frozen Sections
- endpoint definition
- Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.
- time origin
- Immediate
- 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-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 58
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 80
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 75
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- 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 parathyroid surgery. 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 (see Figure 1), as per device functionality requirements.
- analyzed count
- 81
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Standard of Care
- regimen
- The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 79
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05022641-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-parathyroid-cancer
- nct id
- NCT05022641
- harm key
- EG000
- source section id
- NCT05022641-ae
- event group key
- EG000
- event group label
- PTeye
- serious affected
- 0
- serious at risk
- 81
- other affected
- 0
- other at risk
- 81
- frequency threshold
- 0
- collection period
- 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-parathyroid-cancer
- nct id
- NCT05022641
- harm key
- EG001
- source section id
- NCT05022641-ae
- event group key
- EG001
- event group label
- Standard of Care
- serious affected
- 0
- serious at risk
- 79
- other affected
- 0
- other at risk
- 79
- frequency threshold
- 0
- collection period
- 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