- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054986
Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
September 28, 2020 updated by: Memorial Sloan Kettering Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breast Cancer
Breast cancer
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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.
Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days after completion of study treatment and assessments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christopher Riedle, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2019
Primary Completion (Actual)
September 18, 2020
Study Completion (Actual)
September 18, 2020
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 28, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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