Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer

Breast Carcinoma Clinical Trial

Official title:

64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02708511
• Other study ID #: GYNOVA0033
• Secondary ID: NCI-2015-0076732
• Status: Terminated
• Phase: Phase 1
• First received: November 16, 2015
• Last updated: April 4, 2018
• Start date: August 2016
• Est. completion date: October 11, 2017

Study information

• Verified date: April 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 PET/CT 60 minutes post-injection and 24 hours post-injection

After completion of study, patients are followed up for 12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Ovarian Cancer Participants

1. Patient is = 18 years old at the time of the drug administration

2. Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian cancer but is not a surgical candidate

3. Ability to understand and the willingness to sign a written informed consent document.

4. Patient is able to remain still for duration of each imaging procedure

Breast Cancer Participants

1. Patient is = 18 years old at the time of the drug administration

2. Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)

3. Ability to understand and the willingness to sign a written informed consent document.

4. Patient is able to remain still for duration of each imaging procedure

Exclusion Criteria:

Ovarian Cancer Participants

1. Patient is pregnant or breast-feeding

2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.

3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements

4. Patients participating in other research imaging protocols will be excluded from this study.

Breast Cancer Participants

1. Patient is pregnant or breast-feeding

2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.

3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements

4. Patients participating in other research imaging protocols will be excluded from this study.

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• Computed Tomography
Undergo PET/CT

Drug:
• Copper Cu 64-DOTA B-Fab
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Correlative studies

Diagnostic Test:
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanjiv Sam Gambhir

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution of copper Cu 64 DOTA-B-Fab	Determined from serial imaging correlated with blood and urine samples.	24 hours
Primary	Dosimetry of copper Cu 64 DOTA-B-Fab	Determined from serial imaging correlated with blood and urine samples.	120 minutes post-injection