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TerminatedNCT02708511Updated Apr 5, 2018

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

A Phase 1 interventional study of Computed Tomography and Copper Cu 64-DOTA B-Fab in Ovarian Carcinoma and Breast Carcinoma, sponsored by Sanjiv Sam Gambhir. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Sanjiv Sam Gambhir · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Oct 2017, 8 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Carcinoma
  • Breast Carcinoma
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 2 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sanjiv Sam Gambhir is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

    Diagnostic Test: Computed Tomography · Drug: Copper Cu 64-DOTA B-Fab · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Diagnostic Test: Positron Emission Tomography

Interventions

  • Diagnostic testComputed Tomography

    Undergo PET/CT

    Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

  • DrugCopper Cu 64-DOTA B-Fab

    Given IV

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherPharmacological Study

    Correlative studies

  • Diagnostic testPositron Emission Tomography

    Undergo PET/CT

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

06

What researchers measure

Primary outcomes

  1. Biodistribution of copper Cu 64 DOTA-B-Fab

    Determined from serial imaging correlated with blood and urine samples.

    Time frame: 24 hours

  2. Dosimetry of copper Cu 64 DOTA-B-Fab

    Determined from serial imaging correlated with blood and urine samples.

    Time frame: 120 minutes post-injection

07

Study locations

1 site
  • Stanford University, School of Medicine
    Palo Alto, California 94304, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02708511
Lead sponsor
Sanjiv Sam Gambhir
Responsible party
Sanjiv Sam Gambhir (Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University) — Sponsor-investigator
First posted
Mar 15, 2016
Start date
Aug 2016
Primary completion
Oct 11, 2017
Completion
Oct 11, 2017
Last update
Apr 5, 2018

Study contacts

Sanjiv Gambhir
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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