[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/14/2019 |
| Start Date: | May 1, 2017 |
| End Date: | May 2021 |
| Contact: | Robert R Flavell, M.D., Ph.D. |
| Email: | robert.flavell@ucsf.edu |
| Phone: | 917-509-8679 |
Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy
This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG
(VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.
(VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.
This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation
dosimetry of the Positron Emission Tomography [18F]FAraG (VisAcT) in cancer patients selected
for immunotherapy and/or radiation therapy. Each patient may have up to two [ 18F]FAraG PET
imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging
session, patients will receive a single injection of [18F]FAraG and undergo a whole-body PET
scans an hour after injection of the tracer. Following each imaging session, the patient will
be called within 72 hours to note any side effects.
Optional - Blood samples may be collected at up to 9 time points post-injection to analyze
whole-blood/plasma time activity of [18F]FAraG in addition an urine sample may be collected
post scan.
dosimetry of the Positron Emission Tomography [18F]FAraG (VisAcT) in cancer patients selected
for immunotherapy and/or radiation therapy. Each patient may have up to two [ 18F]FAraG PET
imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging
session, patients will receive a single injection of [18F]FAraG and undergo a whole-body PET
scans an hour after injection of the tracer. Following each imaging session, the patient will
be called within 72 hours to note any side effects.
Optional - Blood samples may be collected at up to 9 time points post-injection to analyze
whole-blood/plasma time activity of [18F]FAraG in addition an urine sample may be collected
post scan.
Inclusion Criteria:
- Cancer patients with identified tumor mass
- Cancer patients expected to undergo immunotherapy and/or radiation therapy
Exclusion Criteria:
- Under the age of 18
- Pregnant women
- Women who are breastfeeding
- Individuals with known or suspected substance abuse
- Individuals unable or unwilling to comply with the study procedures
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