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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer | Experimental | Breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-Var3 PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after completion of study treatment and assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Riedle, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood draw | Other | Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |