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

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ClinicalTrials.gov Identifier: NCT02708511
Recruitment Status : Terminated
First Posted : March 15, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Breast Carcinoma Diagnostic Test: Computed Tomography Drug: Copper Cu 64-DOTA B-Fab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Diagnostic Test: Positron Emission Tomography Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study
Study Start Date : August 2016
Actual Primary Completion Date : October 11, 2017
Actual Study Completion Date : October 11, 2017


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
Diagnostic Test: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

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

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies

Diagnostic Test: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Biodistribution of copper Cu 64 DOTA-B-Fab [ Time Frame: 24 hours ]
    Determined from serial imaging correlated with blood and urine samples.

  2. Dosimetry of copper Cu 64 DOTA-B-Fab [ Time Frame: 120 minutes post-injection ]
    Determined from serial imaging correlated with blood and urine samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708511


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Sanjiv Sam Gambhir
Investigators
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Principal Investigator: Sanjiv Gambhir Stanford University

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Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University
ClinicalTrials.gov Identifier: NCT02708511     History of Changes
Other Study ID Numbers: GYNOVA0033
NCI-2015-00767 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
32991
GYNOVA0033 ( Other Identifier: Stanford Cancer Institute )
IRB-32991 ( Other Identifier: Stanford IRB )
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs