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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I have been diagnosed with VHL based on genetic testing or clinical criteria.

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I am 12 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterization of the natural and clinical histories of VHL pancreatic neuroendocrine tumors and cystic lesions

Secondary outcome measures

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

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,114 Total Patients Enrolled

78 Trials studying Neuroendocrine Tumors

42,883 Patients Enrolled for Neuroendocrine Tumors

Naris Nilubol, M.D.Principal InvestigatorNational Cancer Institute (NCI)

8 Previous Clinical Trials

2,705 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are receiving care in this investigation?

"Affirmatively, the information posted on clinicaltrials.gov validates that this trial is presently recruiting study participants. This research was first made available on June 2nd 2020 and last edited October 4th 2022. The investigation requires 740 test subjects at 1 site for completion of the experiment."

Answered by AI

Are there any known health hazards associated with 68-Gallium DOTATATE?

"Our assessment of 68-Gallium DOTATATE's safety was a 2; this is due to the fact that Phase 2 trials have provided some evidence of its security, but not any proof of efficacy."

Answered by AI

Is this an unprecedented attempt at treatment?

"Since 2016, the efficacy of 68-Gallium DOTATATE has been investigated in medical trials. Ozmosis Research Inc sponsored the first study which was conducted with 195 participants and ultimately resulted in N/A drug approval. Now there are currently 15 ongoing examinations into this substance located across 19 urban areas and 13 nations globally."

Answered by AI

Has 68-Gallium DOTATATE been analyzed in any previous research?

"Currently, there are 15 active studies for 68-Gallium DOTATATE with none of them in Phase 3. Most trials are taking place at a medical facility located in Bethesda, Maryland but there is also 47 other sites across the world that offer this clinical trial."

Answered by AI

Are there currently available participation opportunities for this clinical research?

"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants since it was uploaded on June 2nd 2020 and modified most recently in October 4th 2022. The research requires 740 individuals from 1 medical centre location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors

2020. "Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04074135.

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