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Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since May 9, 2026, no change to tracked fieldsv37-v38
  2. Minor Start date changed from estimate of Apr 23, 2026 to Apr 16, 2026v36
  3. Minor Start date: Apr 22, 2026 to Apr 23, 2026v35
  4. Notable Recruitment opened Start date: Apr 21, 2026 to Apr 22, 2026v34 Show 1 more changeShow less
    • Start date: Apr 21, 2026 to Apr 22, 2026
  5. Minor Start date: Apr 20, 2026 to Apr 21, 2026v33
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Apr 19, 2026 to Apr 20, 2026 · Site details revisedv32 Show 2 more changesShow less
    • Start date: Apr 19, 2026 to Apr 20, 2026
    • Site details revised
  2. Minor Start date: Apr 16, 2026 to Apr 19, 2026v31
  3. Minor Start date: Apr 15, 2026 to Apr 16, 2026v30
  4. Minor Start date: Apr 14, 2026 to Apr 15, 2026v29
  5. Minor Start date: Apr 13, 2026 to Apr 14, 2026v28
  6. Minor Start date: Apr 12, 2026 to Apr 13, 2026v27
  7. Minor Start date: Apr 9, 2026 to Apr 12, 2026v26
  1. Notable Primary endpoint(s) modified Start date: Apr 8, 2026 to Apr 9, 2026v25 Show 1 more changeShow less
    • Start date: Apr 8, 2026 to Apr 9, 2026

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Start date: Apr 7, 2026 to Apr 8, 2026v24
  3. Notable Primary endpoints revised (2) Start date: Apr 6, 2026 to Apr 7, 2026 · Eligibility criteria shortened, about 22 words · Secondary endpoint revised · 1 morev23 Show 4 more changesShow less
    • Start date: Apr 6, 2026 to Apr 7, 2026
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoint revised
    • Study description expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Start date: Apr 5, 2026 to Apr 6, 2026v22
  5. Minor Start date: Apr 2, 2026 to Apr 5, 2026v21
  6. Minor Start date: Apr 1, 2026 to Apr 2, 2026v20
  7. Minor Start date: Mar 31, 2026 to Apr 1, 2026v19
  8. Minor Start date: Mar 30, 2026 to Mar 31, 2026v18
  9. Minor Start date: Mar 29, 2026 to Mar 30, 2026v17
  10. Minor Start date: Mar 26, 2026 to Mar 29, 2026v16
  11. Minor Start date: Mar 25, 2026 to Mar 26, 2026v15
  12. Minor Start date: Mar 24, 2026 to Mar 25, 2026v14
  13. Minor Start date: Mar 23, 2026 to Mar 24, 2026v13
  14. Minor Start date: Mar 22, 2026 to Mar 23, 2026v12
  15. Minor Start date: Mar 19, 2026 to Mar 22, 2026v11
  16. Minor Start date: Mar 18, 2026 to Mar 19, 2026v10
  17. Minor Start date: Mar 17, 2026 to Mar 18, 2026v9
  18. Minor Start date: Mar 16, 2026 to Mar 17, 2026v8
  19. Minor Start date: Mar 15, 2026 to Mar 16, 2026v7
  20. Minor Start date: Mar 12, 2026 to Mar 15, 2026v6
  21. Minor Start date: Mar 11, 2026 to Mar 12, 2026v5
  22. Minor Start date: Mar 10, 2026 to Mar 11, 2026v4
  23. Minor Start date: Mar 9, 2026 to Mar 10, 2026v3
  24. Minor Start date: Mar 8, 2026 to Mar 9, 2026v2
  25. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands. Objective: To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands. Eligibility: People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland. Design: Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples. Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine. Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan. Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights. Participants will have a follow-up visit 6 months after the surgery. This may be done remotely....
Trial Details
NCT Number NCT07444723
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Primary Hyperparathyroidism, Parathyroid Cancer, Multiple Endocrine Neoplasias, Heritable Hyperparathyroidism, Hyperparathyroid-jaw Tumor Syndrome
Enrollment 193 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov