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68-Gallium DOTATATE Scan for Von Hippel-Lindau Syndrome

Phase 2
Recruiting
Led By Naris Nilubol, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with at least 1 pancreatic manifestation of VHL as documented on any non-invasive imaging study. These manifestations may include: Pancreatic cyst(s), Solid lesions suspicious for microcystic adenoma(s), Solid enhancing lesions suspicious for PNET(s), Any other solid lesion(s) of the pancreas
Subjects who have been diagnosed with VHL using the following criteria: Identification of a heterozygous germline pathogenic variant in VHL by molecular genetic testing or clinical criteria
Must not have
Inability of subject to undergo serial non-invasive imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding a scan (68-Gallium DOTATATE PET/CT) can detect VHL-related pancreatic tumors that might not be found by other means.

Who is the study for?
This trial is for people aged 12 or older with von Hippel-Lindau (VHL) disease, which causes tumors and cysts in the pancreas. Participants must have a confirmed VHL diagnosis through genetic testing or clinical criteria and be able to give informed consent.
What is being tested?
The study aims to understand how VHL affects the pancreas and assess if a new type of scan called 68-Gallium DOTATATE PET/CT can better detect pancreatic tumors in these patients.
What are the potential side effects?
Since this trial focuses on diagnostic imaging rather than treatment, side effects are minimal but may include discomfort during scans, reactions to contrast agents used for imaging, or anxiety related to undergoing tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have pancreatic issues related to VHL, confirmed by imaging.
Select...
I have been diagnosed with VHL based on genetic testing or clinical criteria.
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I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot have repeated imaging tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterization of the natural and clinical histories of VHL pancreatic neuroendocrine tumors and cystic lesions
Secondary study objectives
distribution of time from initial presentation with pancreatic tumors to the time that surgery is recommended
growth rate in solid pancreatic tumors
predictive value of 68-Gallium DOTATATE PET/CT imaging in patient population

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1/ Arm 1Experimental Treatment1 Intervention
Study natural history of VHL pancreatic neuroendocrine tumors with yearly 68-Gallium DOTATATE PET/CT research scans.
Group II: 2/ Arm 2Active Control1 Intervention
Study natural history of VHL pancreatic neuroendocrine tumors without research scans.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,399 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,033 Patients Enrolled for Neuroendocrine Tumors
Naris Nilubol, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
2,737 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
357 Patients Enrolled for Neuroendocrine Tumors

Media Library

68-Gallium DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT04074135 — Phase 2
Neuroendocrine Tumors Research Study Groups: 2/ Arm 2, 1/ Arm 1
Neuroendocrine Tumors Clinical Trial 2023: 68-Gallium DOTATATE Highlights & Side Effects. Trial Name: NCT04074135 — Phase 2
68-Gallium DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074135 — Phase 2
~493 spots leftby Jan 2036
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