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

April 4, 2018 updated by: Sanjiv Sam Gambhir

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (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
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Diagnostic test: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • tomography
  • CT SCAN
Drug: Copper Cu 64-DOTA B-Fab
Given IV
Diagnostic test: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PET SCAN

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanjiv Sam Gambhir

Investigators

  • Principal Investigator: Sanjiv Gambhir, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

October 11, 2017

Study Completion (Actual)

October 11, 2017

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYNOVA0033 (Other Identifier: Stanford Cancer Institute)
  • NCI-2015-00767 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 32991
  • IRB-32991 (Other Identifier: Stanford IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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