Natural History Study for Familial Carcinoid Tumor

Recruiting at 1 trial location

Overseen By Stephen A Wank, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: MEN I, MEN II, Von Hippel Lindau, others

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

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

Compensation: Varies

Number of Visits: 3

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on families with a history of small bowel carcinoid tumors, which are slow-growing tumors in the digestive tract. Researchers aim to understand tumor development over time, improve early detection, and identify potential genetic causes. Participants will include individuals with a small bowel carcinoid tumor or family members with such tumors. Eligible participants may have siblings or parents with similar tumors or multiple tumors in the small intestine. Participants will undergo various tests, including video capsule endoscopy and scans like [18F]-DOPA PET/CT, to monitor tumor development and spread. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding and early detection of these tumors.

Do I need to stop taking my current medications for the 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 prior data suggests that the procedures used in this study are safe?

Research has shown that [18F]-DOPA is generally safe for people. It is often used in scans for certain types of tumors and other health issues. Studies have found it to be very accurate at ruling out diseases in those who do not have them. However, like any imaging tool, it presents safety concerns. The main issue involves radiation exposure, so using the smallest dose possible is important. Healthcare workers also take special care when handling it. Overall, [18F]-DOPA has been safely used in many medical situations, including those related to Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using [18F]-DOPA for familial carcinoid tumors because it offers a unique way to visualize and assess these tumors using advanced imaging techniques. Unlike standard treatments that focus on managing symptoms or surgically removing tumors, [18F]-DOPA is a radiolabeled compound that allows for precise PET scans, helping doctors better understand the tumor's behavior and progression. This approach could lead to more personalized treatment strategies by providing detailed insights into the tumor's activity, potentially improving outcomes for patients with this condition.

What evidence suggests that this trial's methods could be effective for early detection of small bowel carcinoid tumors?

Research has shown that [18F]-DOPA PET/CT scans effectively identify neuroendocrine tumors (NETs), including carcinoid tumors. Studies have demonstrated that this imaging method can detect tumor activity and spread, which is crucial for early detection and treatment planning. In this trial, participants in Arm 1 will undergo extended evaluation using [18F]-DOPA PET/CT scans at NIH. [18F]-DOPA is a special imaging drug that highlights active tumor areas during PET scans, making it easier for doctors to observe what is happening in the body. This technique is also commonly used in conditions like Parkinson's disease to monitor disease progression and treatment effects. Overall, [18F]-DOPA PET/CT is a promising tool for better managing carcinoid tumors. ^{2 4 6 7 8}

Who Is on the Research Team?

Stephen A Wank, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

Inclusion Criteria

There are four types of participants who will be included in this protocol as outlined below.

Group 1 (Arm 1 or Arm 2)

Have a diagnosis of small intestinal carcinoid tumor Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-5 days

1 visit (in-person)

Diagnostic Evaluation

Participants undergo various diagnostic procedures to determine the presence and spread of carcinoid tumors

3-5 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in tumor status and overall health every 3 years

3 years

1 visit (in-person) every 3 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]-DOPA

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Participants who do not undergo extended screening or evaluation for disease at NIH

Group II: Arm 1 Experimental Treatment 1 Intervention

Participants who undergo extended evaluation for disease at NIH

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

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10805829/

Comparing [18F]FET PET and [18F]FDOPA PET for glioma ...

The purpose of our meta-analysis and systematic review was to evaluate and compare the diagnostic effectiveness of [18F]FET PET and [18F]FDOPA PET in detecting ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0001299824000801

Update on the Role of [ 18 F]FDOPA PET/CT

18 F FDOPA is a radiopharmaceutical used in a broad spectrum of diseases, including neuroendocrine tumors (NETs), congenital hyperinsulinism, parkinsonian ...

3.

imaging-cro.biospective.com

imaging-cro.biospective.com/resources/fdopa-parkinsons-disease-clinical-trials

[18F]DOPA PET in Parkinson's Disease Clinical Trials

[18F]DOPA PET is used to monitor disease progression & response to therapeutic intervention in Parkinson's disease & movement disorders clinical trials.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11429636/

Brain Evaluation by Dual PET/CT with [18F] FDOPA and ...

Brain evaluation by dual PET/CT with 18 F FDOPA and 18 F FDG in differential diagnosis of Parkinsonian syndromes.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06667726

An Investigational Scan (18F-DOPA PET/CT) for Improving ...

Impact of 18F-DOPA PET/CT on clinical management, Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf

FLUORODOPA F 18 Injection - accessdata.fda.gov

risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure. (5.1). ----------- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9123108/

Prospective F-18 FDOPA PET Imaging Study in Human PD

Our prospective study demonstrates high specificity and moderate sensitivity of F-18 FDOPA PET for PD. We received NDA approval in October 2019.

8.

rxlist.com

rxlist.com/fluorodopa-fdopa-f-18-drug.htm

Fluorodopa FDOPA F 18

Drug Handling. Handle Fluorodopa F 18 Injection with appropriate safety measures to minimize radiation exposure [see WARNINGS AND PRECAUTIONS].