Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02708511
Status:
TERMINATED
Last Update Posted:
2018-04-05
First Post:
2015-11-16
Brief Title:
Copper Cu 64-DOTA-B-Fab PETCT in Imaging Patients With Ovarian and Breast Cancer
Sponsor:
Sanjiv Sam Gambhir
Organization:
Stanford University
Study Overview
Official Title:
64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors A First in Human Study
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography PETcomputed tomography CT in imaging patients with ovarian and breast cancer Cancer antigen CA6 is an antigen substance found on the surface of several types of cancer cells such as cancer of the ovary and breast Diagnostic procedures such as copper Cu 64-DOTA-B-Fab PETCT may help identify CA6 positive tumors and allow doctors to plan better treatment
Detailed Description:
PRIMARY OBJECTIVES
I To determine the dosimetry of 64Cu-DOTA B-Fab copper Cu 64-DOTA-B-Fab
SECONDARY OBJECTIVES
I To evaluate the safety of 64Cu-DOTA B-Fab single administration
II To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions
III To compare PET results with the immunohistochemistry IHC analysis of the excised tumor samples
OUTLINE
Patients receive copper Cu 64-DOTA-B-Fab intravenously IV followed by PETCT 60 minutes post-injection and 24 hours post-injection
After completion of study patients are followed up for 12 months
I To determine the dosimetry of 64Cu-DOTA B-Fab copper Cu 64-DOTA-B-Fab
SECONDARY OBJECTIVES
I To evaluate the safety of 64Cu-DOTA B-Fab single administration
II To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions
III To compare PET results with the immunohistochemistry IHC analysis of the excised tumor samples
OUTLINE
Patients receive copper Cu 64-DOTA-B-Fab intravenously IV followed by PETCT 60 minutes post-injection and 24 hours post-injection
After completion of study patients are followed up for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB-32991 | OTHER | Stanford IRB | None |
| NCI-2015-00767 | REGISTRY | None | None |
| 32991 | None | None | None |
| GYNOVA0033 | OTHER | None | None |