18F Fluorocholine PET/CT for Parathyroid Tumors

(18FCH Trial)

Overseen By Andrea Otte, DPT

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Andrei Iagaru

Disqualifiers: Under 18, Low creatinine clearance, others

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT

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. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that 18F-Fluorocholine PET/CT is promising for detecting parathyroid adenomas (small tumors in the parathyroid glands), especially when other imaging methods are inconclusive. It has been effective in localizing hyperparathyroidism (overactive parathyroid glands) and may become a standard tool for identifying parathyroid lesions. ^{1 2 3 4 5}

How is the treatment 18F-Fluorocholine PET/CT different from other treatments for parathyroid tumors?

18F-Fluorocholine PET/CT is unique because it uses a special imaging technique to detect parathyroid tumors, especially when they are small or multiple, and can be more effective than traditional imaging methods when those methods are inconclusive. ^{1 2 6 7 8}

Research Team

Andrei Iagaru, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for people with suspected parathyroid adenoma, which means they have high calcium levels and normal or high parathyroid hormone levels but unclear results from a standard SPECT/CT scan. Participants must be able to consent, have certain liver function test results within acceptable limits, and not be pregnant.

Inclusion Criteria

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

I have high calcium and parathyroid hormone levels, suggesting a parathyroid tumor.

I am able to live my life with some assistance or better.

Exclusion Criteria

I am under 18 years old.

QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome

My kidney function is reduced, with creatinine clearance below 60 mL/min or serum creatinine above 1.5 times the upper limit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive 18F Fluorocholine injection followed by a low dose CT scan and a static PET emission scan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 18Fluorocholine

Trial Overview The study is testing the effectiveness of using Fluorine-18 (18F) bound to Choline in PET/CT scans for identifying parathyroid adenomas when standard imaging with 99mTc Sestamibi SPECT/CT isn't clear. It's a single-center study where all participants will receive the new imaging technique.

Participant Groups

Group I: 18FCH PET/CT Experimental Treatment 1 Intervention

Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area.

18Fluorocholine is already approved in European Union, United States for the following indications:

Approved in European Union as 18F-Fluorocholine for:

• Primary Hyperparathyroidism

Approved in United States as 18F-Fluorocholine for:

• Primary Hyperparathyroidism

Who Is Running the Clinical Trial?

Andrei Iagaru

Lead Sponsor

Trials

16

Recruited

600+

Findings from Research

F-FCH PET-CT demonstrated a high localization success rate of 94.3% for abnormal parathyroid glands in patients with hyperparathyroidism, significantly outperforming conventional imaging methods.

The study involved 44 patients, with F-FCH PET-CT yielding positive results in 77.3% of cases, suggesting it could be a promising second-line imaging option for those with inconclusive ultrasound and sestamibi scintigraphy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 fluorocholine PET-CT localizes hyperparathyroidism in patients with inconclusive conventional imaging: a multicenter study from the Netherlands. Kluijfhout, WP., Vorselaars, WM., van den Berk, SA., et al.[2018]

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 40 patients with suspected primary hyperparathyroidism, 18F-fluorocholine (FCH) PET/CT demonstrated a high sensitivity of 93.3% for detecting hyperfunctioning parathyroid glands, significantly aiding surgical planning.

The study found a strong correlation between parathyroid hormone (PTH) levels and parathyroid size with the semi-quantitative PET parameter SUVratio, suggesting that these factors may influence the diagnostic accuracy of FCH-PET/CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-fluorocholine PET/CT semi-quantitative analysis in patients affected by primary hyperparathyroidism: a comparison between laboratory and functional data. Rizzo, A., Racca, M., Cauda, S., et al.[2023]

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]

18F-fluorocholine (FCH) PET/CT may be a useful tool in detecting parathyroid carcinoma (PTC), a rare tumor associated with primary hyperparathyroidism, although its effectiveness is not yet fully established due to the rarity of the condition.

The case report suggests that combining FCH PET/CT with 18F-fluorodeoxyglucose PET/CT could enhance the evaluation and management of suspected PTC recurrence, which is important given the high rates of local and distant recurrence in this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of recurrent parathyroid carcinoma: A new imaging tool in uncommon entity. Thanseer, NTK., Parihar, AS., Sood, A., et al.[2020]

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]

Early dynamic PET/CT imaging with fluorine-18-fluorocholine (F-FCH) effectively detects parathyroid lesions in patients with primary hyperparathyroidism, showing higher uptake values in adenomas compared to cervical lymph nodes.

The study suggests that early dynamic imaging can differentiate parathyroid adenomas from cervical lymph nodes without needing delayed imaging, potentially streamlining the diagnostic process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the role of early dynamic PET/CT with 18F-fluorocholine in detection of parathyroid lesions in patients with primary hyperparathyroidism. Prabhu, M., Kumari, G., Damle, NA., et al.[2018]

In a study of 271 patients with primary hyperparathyroidism, 18F-fluorocholine (FCH) PET/CT demonstrated a high detection rate of 96% for identifying patients with hyperfunctioning parathyroid glands, making it a promising first-line imaging technique.

The study supports the use of FCH PET/CT in preoperative planning for parathyroid surgery, as it effectively identified single and multiple adenomas, with a 90% detection rate on a per lesion basis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parathyroid imaging with 18F-fluorocholine PET/CT as a first-line imaging modality in primary hyperparathyroidism: a retrospective cohort study. Broos, WAM., Wondergem, M., Knol, RJJ., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Fluorine-18 fluorocholine PET-CT localizes hyperparathyroidism in patients with inconclusive conventional imaging: a multicenter study from the Netherlands. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Fluorocholine PET Imaging of Parathyroid Disease. [2020]

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

18F-fluorocholine PET/CT semi-quantitative analysis in patients affected by primary hyperparathyroidism: a comparison between laboratory and functional data. [2023]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of recurrent parathyroid carcinoma: A new imaging tool in uncommon entity. [2020]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Assessment of the role of early dynamic PET/CT with 18F-fluorocholine in detection of parathyroid lesions in patients with primary hyperparathyroidism. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Parathyroid imaging with 18F-fluorocholine PET/CT as a first-line imaging modality in primary hyperparathyroidism: a retrospective cohort study. [2020]