193 Participants NeededMy employer runs this trial

PET/MR and PET/CT Imaging for Parathyroid Cancer

LM
SJ
Overseen BySmita Jha, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the detection of parathyroid tumors before surgery using advanced imaging scans. It will compare PET/MRI and NeuroEXPLORER PET-CT scans with a special tracer (18F-FCH, a radioactive compound used in imaging) against current imaging methods. The trial targets individuals scheduled for parathyroid gland removal, particularly those with primary hyperparathyroidism or suspected parathyroid cancer. Participants will undergo several imaging sessions and a follow-up after surgery to evaluate the new scans' effectiveness. As a Phase 2, Phase 3 trial, this research assesses the performance of the new imaging methods in preparation for potential FDA approval, allowing participants to contribute to advancements in medical imaging.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using any investigational products or devices, you must stop them at least 30 days before the 18F-FCH scan.

What prior data suggests that PET/MRI and NeuroEXPLORER PET-CT scans with 18F-FCH tracer are safe for imaging parathyroid cancer?

Research has shown that 18F-fluorocholine (18F-FCH) is generally safe and well-tolerated. Studies have found it to be a safe substance for use in imaging scans. One study demonstrated that 18F-FCH PET scans successfully identified parathyroid tumors in 93% of patients, proving especially helpful when other methods failed.

Importantly, these studies reported no major side effects in participants. Although the tracer collects in some other tissues, this has not led to any significant safety issues.

Overall, previous studies suggest that using 18F-FCH in scans is safe and can help doctors accurately identify parathyroid problems before surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the use of 18F-FCH in imaging for parathyroid cancer because it provides a more precise way to locate cancerous tissues compared to traditional imaging techniques like ultrasound or standard CT scans. 18F-FCH is a radioactive tracer that highlights parathyroid cancer cells during PET/CT and PET/MRI scans, offering high-resolution images that can lead to better diagnosis and treatment planning. This method could enhance the accuracy of tumor detection, potentially improving outcomes for patients with parathyroid cancer.

What evidence suggests that PET/MRI and NeuroEXPLORER PET-CT scans with 18F-FCH tracer are effective for finding parathyroid glands?

Studies have shown that the 18F-FCH tracer used in PET scans effectively detects parathyroid tumors. Research indicates that this tracer surpasses older imaging methods like ultrasound or SPECT in accuracy. Specifically, one study found that 18F-FCH PET/CT correctly identified tumors in up to 91.7% of cases. Other studies have confirmed its effectiveness for both new and recurrent cases of parathyroid disease. Overall, 18F-FCH PET scans are considered reliable for locating these elusive glands before surgery. Participants in this trial will receive an 18F-FCH injection for use in PET/CT and PET/MRI imaging.56789

Who Is on the Research Team?

SJ

Smita Jha, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

This trial is for adults (18+) who need surgery to remove a parathyroid gland due to conditions like hyperparathyroidism, parathyroid tumors, or related genetic syndromes. People who are pregnant, breastfeeding, allergic to the tracer dye, or unable to consent cannot join.

Inclusion Criteria

I am willing to have parathyroid surgery at the NIH Clinical Center.
I have sporadic primary hyperparathyroidism and may need parathyroid surgery.
I am between 18 and 100 years old.
See 2 more

Exclusion Criteria

Pregnancy or lactation
Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical
I am not willing to use effective birth control before and during my surgery period.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Imaging

Participants undergo 4D-CT scan with iodine-based dye and PET/MRI and NeuroEXPLORER PET-CT scans with 18F-FCH tracer

1 day
1 visit (in-person)

Surgery

Participants undergo surgery to remove the target parathyroid gland

1-3 days
1 visit (in-person, possible hospital stay)

Follow-up

Participants are monitored for safety and effectiveness after surgery

6 months
1 visit (remote)

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-FCH
  • NeuroEXPLORER

Trial Overview

The study compares new imaging scans—PET/MRI and NeuroEXPLORER PET-CT using a radioactive tracer called 18F-FCH—to standard CT scans in finding abnormal parathyroid glands before surgery. Participants receive both types of scans as part of the research.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single-ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials
2,513
Recruited
4,366,000+

Citations

Fluorocholine PET Imaging of Parathyroid Disease - PMC - NIH

Results of various studies have shown that 18F-FCH is a promising upcoming tracer for the detection of parathyroid adenomas, especially when multiple, or having ...

18F-choline PET/CT and PET/MRI in primary and recurrent ...

FCH PET/CT is more accurate than conventional morphological and functional imaging modalities (US or SPET) for the detection of benign parathyroid lesions.

Accuracy of 18F-Fluorocholine PET/MR and ...

Study Description: This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary ...

[ 18 F]Fluorocholine PET/MRI and [ 18 F ... - Springer Nature

Both [ 18 F]FCH PET/MRI and [ 18 F]FCH PET/CT are highly accurate imaging modalities for localizing parathyroid adenomas in both first- and second-line ...

Contribution of 18 F-fluorocholine PET-CT to the ...

A review of six studies also found high sensitivity for 18 F-fluorocholine PET-CT (90 to 91.7%) even in the presence of coexisting nodular ...

Incidental Findings on 18 F-Fluorocholine PET/CT for ... - PMC

18 F-choline is a nonspecific tracer that also accumulates in malignancies, inflammatory lesions, and several other benign abnormalities.

NCT07444723 | Accuracy of 18F-Fluorocholine PET/MR ...

This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary hyperparathyroidism (sporadic or heritable ...

Evaluating Fluorine-18–Fluorocholine Positron Emission ...

This study aimed to evaluate FCH-PET/CT as a first-line procedure for localizing potential parathyroid adenomas in a real-world setting and establish benefits ...

Clinical application of 18F-FCH PET/CT in the diagnosis and ...

Few studies have found that 18F-FCH PET/CT has more advantages in the diagnosis of parathyroid adenomas, but its usefulness in diagnosis of ...