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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scanning method to better identify parathyroid tumors, which are small abnormal growths that can elevate calcium levels in the blood. The researchers use a special PET/CT scan with 18F Fluorocholine (a radiotracer) to determine if it can detect tumors when usual scans do not provide clear results. Suitable participants have high calcium and parathyroid hormone levels but unclear results from standard scans. As a Phase 2, Phase 3 trial, this research measures the effectiveness of the scanning method in an initial group and is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in tumor detection.

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.

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

Research shows that 18F-Fluorocholine PET/CT is generally safe for patients. Studies have found it to be well-tolerated, with no major safety concerns reported. One study used this imaging method to find parathyroid adenomas, yielding positive results without serious side effects for patients.

Another study with 151 patients who had primary hyperparathyroidism (a condition where the parathyroid glands produce too much hormone) also used 18F-Fluorocholine PET/CT safely. This suggests the procedure does not pose major risks to participants.

Since this study is in the later phases of clinical trials, the procedure has already passed initial safety tests in earlier studies. This indicates that 18F-Fluorocholine PET/CT is likely safe for further use in detecting parathyroid issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 18F Fluorocholine PET/CT for parathyroid tumors because it offers a new way to precisely locate these tumors. Unlike traditional imaging methods like ultrasound or sestamibi scans, 18F Fluorocholine PET/CT uses a radioactive tracer that highlights tumors more clearly, potentially leading to more accurate diagnoses. This method could improve surgical outcomes by helping doctors pinpoint exactly where to operate, reducing the risk of missing small tumors. The precision of this imaging technique offers a promising advancement in how parathyroid tumors are detected and treated.

What evidence suggests that 18F-Fluorocholine PET/CT is effective for detecting parathyroid tumors?

Research has shown that 18F-fluorocholine PET/CT scans excel at detecting parathyroid adenomas, especially when other methods fall short. One study found that it correctly identified at least one tumor in 94% of patients who later underwent surgery. This scan is considered superior for locating these tumors pre-surgery. Some studies also suggest it is a cost-effective diagnostic tool. Overall, evidence supports that 18F-fluorocholine PET/CT is a reliable and accurate method for detecting parathyroid tumors. Participants in this trial will undergo the 18F-fluorocholine PET/CT scan to assess its effectiveness in identifying parathyroid tumors. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrei Iagaru, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612343/

Accuracy of 18F-Fluorocholine PET for the Detection of ... European centers have shown 18F-fluorocholine PET to be highly accurate in the detection of parathyroid adenomas (9), particularly among patients with negative ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251984

Performance of 18F-fluorocholine PET/CT for Localization of ... In the 35 patients who underwent parathyroidectomy, FCH PET/CT correctly identified at least one lesion in 33 (94%) patients. There was a >50% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X25012522

Evaluating [18F]fluorocholine PET/CT as a first-line ... Impact of perioperative diagnostic tools on clinical outcomes and cost-effectiveness in parathyroid surgery: a decision model-based analysis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11457719/

Cost-effectiveness of one-stop-shop [18F]Fluorocholine ... This study explored the cost-effectiveness of two imaging strategies to localise parathyroid adenomas and to guide succeeding treatment for ...

5. nature.com nature.com/articles/s41598-025-94735-2

Contribution of 18 F-fluorocholine PET-CT to the ... - Nature Conclusion. Our study demonstrates the superiority of 18 F-fluorocholine PET-CT in the preoperative localisation of parathyroid adenomas in ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/61/4/577

18F-Fluorocholine PET/CT in Primary Hyperparathyroidism ... In the subgroup with a single parathyroid adenoma (87 patients) 18F-fluorocholine PET/CT had a sensitivity of 95.5% and specificity of 99.7% for ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT03764007/Prot_SAP_000.pdf

18F-Fluorocholine for the Detection of Parathyroid Adenomas Each patient receiving 18F-fluorocholine will be evaluable for safety. The ... All 18F-fluorocholine imaging data will be anonymized and collected. PET ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0001299824000758

18F-Fluorocholine-Positron Emission Tomography ... concluded from their retrospective analysis of series of 151 patients with pHPT, that patients with a single parathyroid adenoma on FCH PET can safely undergo ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6097754/

18F-Fluorocholine PET/CT in the assessment of primary ... In this prospective study, 18F-fluorocholine PET/CT showed promise as a functional imaging modality, being clearly superior to 99mTc-MIBI/tetrofosmin SPECT/CT, ...