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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
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 9, 2019
First Posted Date  ICMJE August 13, 2019
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE August 9, 2019
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
Official Title  ICMJE 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
Brief Summary The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Breast Cancer
Breast cancer
Interventions:
  • Diagnostic Test: F-Var3 PET/CT
  • Other: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2020)
6
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
10
Actual Study Completion Date  ICMJE September 18, 2020
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or greater
  • Biopsy-proven breast malignancy
  • >/= 1 viable lesion, >/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment
  • Newly diagnosed or recurrent disease, on or off therapy
  • ECOG performance of 0-2 *Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions

Exclusion Criteria:

  • Life expectancy < 3 months
  • Pregnancy or lactation
  • Biopsy or other surgical procedures within 48 hours prior to receiving study intervention
  • Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04054986
Other Study ID Numbers  ICMJE 19-147
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Riedle, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP