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New treatment option for Primary Hyperparathyroidism
Official title Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
ClinicalTrials.gov ID: NCT07444723
What this study is testing
What is 18F-FCH?
18F-FCH is an investigational medicine, being studied as a potential treatment for primary hyperparathyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18-100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Meets one of the following:
- Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan...
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
- Unable or unwilling to provide informed consent.
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18-100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Meets one of the following:
- Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
- Diagnosed with any forms of heritable primary hyperparathyroidism (index presentation or recurrent disease) and is a potential candidate for parathyroidectomy. Participants clinically suspected of multi-gland disease...
- Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
- Unable or unwilling to provide informed consent.
- Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.