TriangleNCT05152927 · STUDY IN CONTEXT
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
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
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
- NCT05152927
- trial label
- 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-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0000
- source section id
- NCT05152927-om-0000
- source outcome index
- 0
- endpoint
- Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
- endpoint definition
- Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
- time origin
- At the end of the parathyroidectomy, up to 5 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-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0001
- source section id
- NCT05152927-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Persistent Hyperparathyroidism (Immediate)
- endpoint definition
- Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
- time origin
- 5-14 days 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-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0002
- source section id
- NCT05152927-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)
- endpoint definition
- Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
- time origin
- 5-14 days after PTx procedure
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.
- 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
- NCT05152927
- outcome key
- om-0003
- source section id
- NCT05152927-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants 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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
- time origin
- Up to 6 months after PTx procedure
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants from both groups were missing labs. Not all PTEye participants returned to the clinic for blood draws within 5-14 days to obtain lab values required to calculate this endpoint and standard clinical care does not necessitate participants returning for labs routinely at each follow-up time points.
- 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
- NCT05152927
- outcome key
- om-0004
- source section id
- NCT05152927-om-0004
- source outcome index
- 4
- endpoint
- Number of Parathyroid Glands (PG) Identified
- endpoint definition
- Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
- time origin
- At the end of the parathyroidectomy, up to 5 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-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0005
- source section id
- NCT05152927-om-0005
- source outcome index
- 5
- endpoint
- Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
- endpoint definition
- Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
- time origin
- At the end of the parathyroidectomy, up to 5 hours
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only 4 participants had glands identified with NIRAF, which was not seen with surgeon's naked eye
- 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
- NCT05152927
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Usual Standard of Care
- regimen
- The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Usual Standard of Care
- regimen
- The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Usual Standard of Care
- regimen
- The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Usual Standard of Care
- regimen
- The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 38
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Usual Standard of Care
- regimen
- The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Parathyroid Eye (PTeye)
- regimen
- For participants assigned to the study arm, 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.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05152927-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-endocrine-carcinoma
- nct id
- NCT05152927
- harm key
- EG000
- source section id
- NCT05152927-ae
- event group key
- EG000
- event group label
- Parathyroid Eye (PTeye)
- serious affected
- 2
- serious at risk
- 38
- other affected
- 0
- other at risk
- 38
- frequency threshold
- 5
- collection period
- Up to 6 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-endocrine-carcinoma
- nct id
- NCT05152927
- harm key
- EG001
- source section id
- NCT05152927-ae
- event group key
- EG001
- event group label
- Usual Standard of Care
- serious affected
- 5
- serious at risk
- 41
- other affected
- 0
- other at risk
- 41
- frequency threshold
- 5
- collection period
- Up to 6 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