18F-Fluorocholine PET for Parathyroid Adenomas

Recruiting in Palo Alto (17 mi)

Overseen by Thomas A. Hope, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Thomas Hope

Disqualifiers: Pregnancy, Non-compliance, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment 18F-Fluorocholine for parathyroid adenomas?

Research shows that 18F-Fluorocholine PET imaging is helpful in accurately locating parathyroid adenomas, especially when other imaging methods like ultrasound and scintigraphy give unclear results. This can be particularly useful for planning surgery in patients with primary hyperparathyroidism, making the treatment more effective. ^{1 2 3 4 5}

How does 18F-Fluorocholine PET differ from other treatments for parathyroid adenomas?

18F-Fluorocholine PET is a new imaging technique that helps locate parathyroid adenomas more accurately than traditional methods like ultrasound and scintigraphy. This allows for targeted, minimally invasive surgery, reducing the need for extensive exploration and its associated risks. ^{1 6 7 8 9}

Research Team

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• 18F-Fluorocholine (Radiopharmaceutical)

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The role of F18-fluorocholine positron emission tomography/magnetic resonance imaging in localizing parathyroid adenomas. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Benefit of 18F-fluorocholine PET imaging in parathyroid surgery. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Challenging pre-surgical localization of hyperfunctioning parathyroid glands in primary hyperparathyroidism: the added value of 18F-Fluorocholine PET/CT. [2019]

4. India 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. [2023]

5. India 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. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Fluorocholine PET Imaging of Parathyroid Disease. [2020]

7. Romania 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[18F-Fluorocholine PET-CT for localization of parathyroid adenomas]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Fluorine-18 Fluorocholine Positron Emission Tomography/Computed Tomography in Primary Hyperparathyroidism: A Case Report and Review of Literature. [2022]