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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00767 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 32991 | |||
| GYNOVA0033 | Other Identifier | Stanford Cancer Institute | |
| IRB-32991 | Other Identifier | Stanford IRB |
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This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer antigen (CA)6 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 PET/CT, may help identify CA6 positive tumors and allow doctors to plan better treatment.
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 PET/CT 60 minutes post-injection and 24 hours post-injection
After completion of study, patients are followed up for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (Cu 64 DOTA-B-Fab) | Experimental | Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Diagnostic Test | Undergo PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of copper Cu 64 DOTA-B-Fab | Determined from serial imaging correlated with blood and urine samples. | 24 hours |
| Dosimetry of copper Cu 64 DOTA-B-Fab | Determined from serial imaging correlated with blood and urine samples. | 120 minutes post-injection |
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Inclusion Criteria:
Ovarian Cancer Participants
Breast Cancer Participants
Exclusion Criteria:
Ovarian Cancer Participants
Breast Cancer Participants
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Gambhir | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D014054 | Tomography |
| D049268 | Positron-Emission Tomography |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Copper Cu 64-DOTA B-Fab | Drug | Given IV |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Pharmacological Study | Other | Correlative studies |
|
| Positron Emission Tomography | Diagnostic Test | Undergo PET/CT |
|
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014055 | Tomography, Emission-Computed |
| D011877 | Radionuclide Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |