[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03142204|
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : December 5, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: [18F]F-AraG||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
- Drug: [18F]F-AraG
Single dose IV injection of [18F]F-AraG for each imaging day.
- Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy [ Time Frame: Up to 6 weeks before immunotherapy is administered ]Whole-body [18F]F-AraG PET scan will be performed after intravenous injection of the PET tracer.consecutive time points the day of the intravenous injection of the PET tracer.
- Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy [ Time Frame: Up to 12 weeks after start of immunotherapy ]Whole-body [18F]F-AraG PET scan will be performed after intravenous injection of the PET tracer.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Cancer patients with identified tumor mass
- Cancer patients expected to undergo immunotherapy and/or radiation therapy
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142204
|Contact: Robert R Flavell, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Henry VanBrocklin, Ph.D.||email@example.com|
|United States, California|
|UCSF Imaging Center at China Basin||Recruiting|
|San Francisco, California, United States, 94107|
|Contact: Maya Aslam 415-514-8987 firstname.lastname@example.org|
|Contact: Katherine Wu 415-353-9437 email@example.com|
|Principal Investigator:||Robert R Flavell, M.D., Ph.D.||UCSF Department of Radiology & Biomedical Imaging|
|Responsible Party:||CellSight Technologies, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 5, 2017 Key Record Dates|
|Last Update Posted:||December 5, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|