18F-Fluorocholine PET for Parathyroid Adenomas

Overseen By Leena Awni

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Thomas Hope

Disqualifiers: Pregnancy, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to locate parathyroid adenomas, small growths on the parathyroid glands that can cause health issues. The study employs a special imaging technique called 18F-fluorocholine PET to identify these adenomas before surgery. It suits individuals diagnosed with hyperparathyroidism, a condition where the parathyroid glands produce excess hormone, who are planning surgery. Participants will undergo one imaging session to determine if this method can accurately pinpoint the adenomas. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking diagnostic method.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that 18F-Fluorocholine is likely to be safe for humans?

Research has shown that 18F-fluorocholine is a promising method for detecting parathyroid adenomas, which are small growths in the parathyroid glands. Studies have found that this type of PET scan effectively locates even small or hidden adenomas. Regarding safety, past research has not reported any major side effects from using 18F-fluorocholine, suggesting it is generally safe. The advanced stage of this study indicates that earlier trials did not find significant safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

18F-Fluorocholine PET imaging is unique because it uses a radioactive tracer to help identify parathyroid adenomas more effectively than traditional imaging techniques like ultrasound or sestamibi scans. What sets it apart is its ability to provide clearer, more precise images, which can lead to better surgical outcomes by accurately pinpointing the adenomas. Researchers are excited about this technique because it might offer a faster and more reliable way to diagnose and plan treatment for patients with hyperparathyroidism, potentially improving surgical success rates and reducing the need for additional procedures.

What evidence suggests that 18F-Fluorocholine PET is effective for detecting parathyroid adenomas?

Research has shown that 18F-fluorocholine PET scans, which participants in this trial will undergo, effectively detect parathyroid adenomas, small growths in the parathyroid glands. One study found that this method correctly identified at least one growth in 94% of patients. Other studies also highlight its accuracy, especially for patients where traditional methods were ineffective. Experts consider it a top choice for locating these growths before surgery. This imaging method has proven superior in detecting parathyroid adenomas compared to other techniques. ^{2 6 7 8 9}

Who Is on the Research Team?

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals aged 13 or older with biochemically proven hyperparathyroidism who need surgery. Participants must be able to understand and sign a consent form. Pregnant individuals or those unlikely to follow study procedures are not eligible.

Inclusion Criteria

I am 13 years old or older.

I am 13 years old or older.

Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

Current Pregnancy

Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single dose of 18F-Fluorocholine and undergo a PET imaging study

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluorocholine

Trial Overview

The study is testing the effectiveness of a substance called 18F-Fluorocholine used in PET scans to locate parathyroid adenomas in patients with primary hyperparathyroidism.

How Is the Trial Designed?

Group I: Fluorocholine PET Imaging Experimental Treatment 2 Interventions

Patients will undergo a single fluorocholine PET imaging study prior to surgery.

Who Is Running the Clinical Trial?

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Published Research Related to This Trial

In a study of 28 patients with primary hyperparathyroidism, 18F-fluorocholine (FCH) PET/CT successfully detected lesions in 92.9% of cases, demonstrating high diagnostic performance for identifying hyper-functioning parathyroid glands.

Repeated ultrasonography (USG) also showed a high lesion detection rate of 95.7%, indicating that both imaging techniques are effective and can be used together for early detection and localization of parathyroid lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DIAGNOSTIC PERFORMANCES OF 18F-FLUOROCHOLINE POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY AND REPEATED ULTRASONOGRAPHY IN DETECTING UNDEFINED LESIONS IN PATIENTS WITH AN INDICATION FOR PRIMARY HYPERPARATHYROIDISM SURGERY. Yildiz, R., Şan, H., Alagöz, E.[2023]

18F-fluorocholine PET-CT is an effective imaging technique for locating pathological parathyroid glands in patients with primary hyperparathyroidism, especially when traditional methods fail.

This imaging modality allows for targeted minimally invasive surgery, reducing the need for extensive procedures and the associated risks and side effects of medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F-Fluorocholine PET-CT for localization of parathyroid adenomas]. Kluijfhout, WP., Vriens, MR., Borel Rinkes, IH., et al.[2018]

F18-fluorocholine positron emission tomography/magnetic resonance imaging (PET/MRI) successfully localized parathyroid adenomas in 84.2% of cases and accurately predicted the affected side in 100% of patients, showing its potential as a reliable imaging tool.

In comparison to traditional methods like ultrasound and technetium-99m scintigraphy, PET/MRI was more accurate in localizing adenomas, particularly identifying cases that other methods missed, although no significant differences were found when comparing all three modalities together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of F18-fluorocholine positron emission tomography/magnetic resonance imaging in localizing parathyroid adenomas. Khafif, A., Masalha, M., Landsberg, R., et al.[2020]

In a study of 55 patients with primary hyperparathyroidism, 18F-fluorocholine (FCH) PET/CT demonstrated a high detection rate of 97.6% for localizing abnormal parathyroid lesions, significantly outperforming 99mTc-sestamibi scintigraphy (78.5%) and neck ultrasonography (71.4%).

The study suggests that 18F-FCH PET/CT should be considered as a first-line imaging technique for preoperative localization of parathyroid adenomas, enhancing surgical planning and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Neck Ultrasonography, Dual Phase 99mTc-Sestamibi with early SPECT-CT & 18F-Fluorocholine PET-CT as First Line Imaging in Patients with Primary Hyperparathyroidism. Abhishek, B., Wakankar, R., Dharmashaktu, Y., et al.[2023]

In a study of 26 patients with hyperparathyroidism, 18F-fluorocholine PET imaging successfully detected parathyroid adenomas in 96.2% of cases where previous ultrasound and scintigraphy were inconclusive.

The accuracy of 18F-fluorocholine PET imaging was confirmed during surgery, as the predicted locations matched intraoperative findings, eliminating the need for revision surgeries post-operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of 18F-fluorocholine PET imaging in parathyroid surgery. Huber, GF., Hüllner, M., Schmid, C., et al.[2020]

18F-fluorocholine PET/CT (FCH PET/CT) shows promise as an effective imaging tool for detecting parathyroid adenomas, particularly in cases where the adenomas are small or multiple.

The studies suggest that FCH PET/CT could become a standard method for identifying parathyroid lesions in patients with primary and secondary hyperparathyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorocholine PET Imaging of Parathyroid Disease. Prabhu, M., Damle, NA.[2020]

In a study of 27 patients with primary hyperparathyroidism, 18F-Fluorocholine (18F-FCH) PET/CT successfully localized hyper-functioning parathyroid glands in 24 patients, demonstrating a high positive predictive value of 94%.

The technique showed particularly high sensitivity in patients with familial hyperparathyroidism and multiple gland disease, achieving 100% sensitivity for patient-level detection, making it a valuable tool for challenging cases where standard imaging methods were inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging pre-surgical localization of hyperfunctioning parathyroid glands in primary hyperparathyroidism: the added value of 18F-Fluorocholine PET/CT. Grimaldi, S., Young, J., Kamenicky, P., et al.[2019]

In a case study of a 72-year-old woman with suspected primary hyperparathyroidism, 18F-Fluorocholine PET/CT successfully identified a right parathyroid adenoma that was missed by conventional imaging methods, enabling effective treatment.

The use of 18F-Fluorocholine PET/CT facilitated a safe and minimally invasive parathyroidectomy, leading to clinical and biochemical remission in the patient, highlighting its potential as a reliable diagnostic tool in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 Fluorocholine Positron Emission Tomography/Computed Tomography in Primary Hyperparathyroidism: A Case Report and Review of Literature. Ramalho, D., Rocha, G., Oliveira, JM., et al.[2022]

In a study of 20 patients with recurrent primary hyperparathyroidism, 18F-Fluorocholine (18F-FCH) PET/CT demonstrated a high accuracy for detecting parathyroid lesions, achieving a 100% detection rate in patients who underwent surgery.

When compared to other imaging techniques, 18F-FCH PET/CT showed similar effectiveness to 99mTc-Sestamibi scintigraphy, with both methods having a 100% lesion detection rate in the surgical cohort, indicating its reliability for preoperative localization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18Fluorocholine Positron Emission Tomography/Computed Tomography in the Localization of Culprit Lesions in Patients of Persistent/Recurrent Primary Hyperparathyroidism: A Prospective Study in COVID Times. Wakankar, R., Dharmashaktu, Y., Damle, AN., et al.[2023]

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This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.