NCT02708511

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

November 16, 2015

Last Update Submit

April 4, 2018

Conditions

Ovarian CarcinomaBreast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Biodistribution of copper Cu 64 DOTA-B-Fab

    Determined from serial imaging correlated with blood and urine samples.

    24 hours

  • Dosimetry of copper Cu 64 DOTA-B-Fab

    Determined from serial imaging correlated with blood and urine samples.

    120 minutes post-injection

Study Arms (1)

Diagnostic (Cu 64 DOTA-B-Fab)

EXPERIMENTAL

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 TomographyDrug: Copper Cu 64-DOTA B-FabOther: Laboratory Biomarker AnalysisOther: Pharmacological StudyDiagnostic Test: Positron Emission Tomography

Interventions

Computed TomographyDIAGNOSTIC_TEST

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Diagnostic (Cu 64 DOTA-B-Fab)
Copper Cu 64-DOTA B-FabDRUG

Given IV

Diagnostic (Cu 64 DOTA-B-Fab)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Diagnostic (Cu 64 DOTA-B-Fab)
Pharmacological StudyOTHER

Correlative studies

Diagnostic (Cu 64 DOTA-B-Fab)
Positron Emission TomographyDIAGNOSTIC_TEST

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
Diagnostic (Cu 64 DOTA-B-Fab)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ovarian Cancer Participants
  • Patient is ≥ 18 years old at the time of the drug administration
  • 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
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient is able to remain still for duration of each imaging procedure
  • Breast Cancer Participants
  • Patient is ≥ 18 years old at the time of the drug administration
  • Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient is able to remain still for duration of each imaging procedure

You may not qualify if:

  • Ovarian Cancer Participants
  • Patient is pregnant or breast-feeding
  • Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
  • Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
  • Patients participating in other research imaging protocols will be excluded from this study.
  • Breast Cancer Participants
  • Patient is pregnant or breast-feeding
  • Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
  • Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
  • Patients participating in other research imaging protocols will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsBreast Neoplasms

Interventions

Tomography, X-Ray ComputedTomographyPositron-Emission Tomography

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography, Emission-ComputedRadionuclide ImagingDiagnostic Techniques, Radioisotope

Study Officials

  • Sanjiv Gambhir

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research

Study Record Dates

First Submitted

November 16, 2015

First Posted

March 15, 2016

Study Start

August 1, 2016

Primary Completion

October 11, 2017

Study Completion

October 11, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)