Study on Ultralow Dose PET Imaging with 18F-FDOPA
Sponsor: Akiva Mintz
ClinicalTrials ID:NCT07542158
This clinical trial is testing a new PET imaging technique that uses a very low dose of radiation to help detect and monitor Parkinsonian syndromes, neuroendocrine tumors, and gliomas. The study aims to see if this method can provide clear images while significantly reducing radiation exposure.
Patient Parameters
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Program Overview
The purpose of this study is to test a new PET imaging method that uses a much lower dose of radiation than usual to detect and monitor conditions like Parkinsonian syndromes, neuroendocrine tumors, and gliomas. Participants will receive a small amount of a radioactive tracer called 18F-FDOPA and undergo imaging on a high sensitivity PET scanner for up to 3 hours. The study aims to find out if it's possible to get clear images with much less radiation, making the process safer and potentially allowing for more frequent use in monitoring these conditions.
Description
This study is exploring a new PET imaging technique that uses a very low dose of radiation to help detect and monitor Parkinsonian syndromes, neuroendocrine tumors, and gliomas. The technique is considered investigational because it is not yet approved by the FDA for this specific use. The radioactive tracer used, 18F-FDOPA, is already approved for detecting prostate cancer at standard doses, but this study uses much less of it—less than 1/20th of the usual amount.
The goal is to see if this ultralow dose can still produce clear images, which would make the imaging process safer and allow it to be used more often for checking these conditions. The study will include about 200 participants, both with and without these conditions, to see how well the ultralow dose PET imaging works in different types of tissue.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be able to understand the study and agree to participate.
- For women, must not be pregnant or breastfeeding and must have a negative pregnancy test if they are of childbearing age.
Exclusion Criteria
- Have already received too much radiation from previous research scans.
- Have participated in this study more than four times before.
- Have severe claustrophobia, chronic pain, or conditions that make it hard to complete the PET scan.
- Are taking treatments that might interfere with the imaging results.
- Are pregnant or breastfeeding.
- Cannot provide informed consent.
- Have any condition that might affect safety or the study's results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Nuclear Imaging Institute | 07631 | Englewood | New Jersey |
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