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Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-Var3 PET/CT
Blood draw
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, 18F-Var3, First in human, Acidosis imaging, Memorial Sloan Kettering Cancer Center, 19-147

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast Cancer

Arm Description

Breast cancer

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2019
Last Updated
September 28, 2020
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04054986
Brief Title
Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
September 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, 18F-Var3, First in human, Acidosis imaging, Memorial Sloan Kettering Cancer Center, 19-147

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer
Arm Type
Experimental
Arm Description
Breast cancer
Intervention Type
Diagnostic Test
Intervention Name(s)
F-Var3 PET/CT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
Description
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.
Time Frame
30 days after completion of study treatment and assessments

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Riedle, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer

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