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

Phase 1

Terminated

• Conditions: Ovarian Carcinoma; Breast Carcinoma
• Interventions: Diagnostic Test: Computed Tomography; Drug: Copper Cu 64-DOTA B-Fab; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Diagnostic Test: Positron Emission Tomography

• Registration Number: NCT02708511
• Lead Sponsor: Sanjiv Sam Gambhir

Brief 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.

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

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

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Study Start: 2016-08
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (Cu 64 DOTA-B-Fab)	Computed Tomography	Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Diagnostic (Cu 64 DOTA-B-Fab)	Copper Cu 64-DOTA B-Fab	Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Diagnostic (Cu 64 DOTA-B-Fab)	Laboratory Biomarker Analysis	Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Diagnostic (Cu 64 DOTA-B-Fab)	Pharmacological Study	Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Diagnostic (Cu 64 DOTA-B-Fab)	Positron Emission Tomography	Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection

Primary Outcome Measures

Name	Time	Method
Biodistribution of copper Cu 64 DOTA-B-Fab	24 hours	Determined from serial imaging correlated with blood and urine samples.
Dosimetry of copper Cu 64 DOTA-B-Fab	120 minutes post-injection	Determined from serial imaging correlated with blood and urine samples.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States