Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04054986|
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Diagnostic Test: F-Var3 PET/CT Other: Blood draw||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study Using First-in-Human Acidosis Imaging With [18F]AlF-cysVar3 pHLIP® (18F-Var3) in Patients With Breast Cancer for Determination of Safety, Biodistribution and Radiation Dosimetry|
|Actual Study Start Date :||August 9, 2019|
|Actual Primary Completion Date :||September 18, 2020|
|Actual Study Completion Date :||September 18, 2020|
Experimental: Breast Cancer
Diagnostic Test: F-Var3 PET/CT
Participants will undergo up to 5 serial F-Var3 PET/CT scans within 25 minutes of the injection of 18F-Var3, 30, 60, 120 and 240 minutes after injection of the 18FVar3.
Other: Blood draw
Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 [ Time Frame: 30 days after completion of study treatment and assessments ]The safety of patients will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 and grade 2 toxicities are considered safe.
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): NCT04054986
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Christopher Riedle, MD, PhD||Memorial Sloan Kettering Cancer Center|