Ovarian CarcinomaPhase 1NCT02708511
Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
A Phase 1 study testing Computed Tomography, Copper Cu 64-DOTA B-Fab and Laboratory Biomarker Analysis in people with Ovarian Carcinoma and Breast Carcinoma, run by Sanjiv Sam Gambhir at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma, Breast Carcinoma
- What is being tested?
- Computed Tomography, Copper Cu 64-DOTA B-Fab and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 11 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Ovarian Carcinoma, Breast Carcinoma
- Being tested
- Computed Tomography, Copper Cu 64-DOTA B-Fab, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyDiagnostic test
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT
Copper Cu 64-DOTA B-FabDrug
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
Positron Emission TomographyDiagnostic test
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Computed Tomography; Drug: Copper Cu 64-DOTA B-Fab; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Diagnostic Test: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodistribution of copper Cu 64 DOTA-B-Fab
Determined from serial imaging correlated with blood and urine samples.
Measured: 24 hours
Dosimetry of copper Cu 64 DOTA-B-Fab
Determined from serial imaging correlated with blood and urine samples.
Measured: 120 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjiv Sam Gambhir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanjiv Sam Gambhir, Stanford University
- Investigators
- Sanjiv Gambhir, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708511
- Sponsor's protocol ID
- GYNOVA0033
- Other IDs
- NCI-2015-00767, 32991, GYNOVA0033, IRB-32991
- Status last verified
- Apr 2018
- First submitted
- 16 Nov 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study
- ClinicalTrials.gov ID
- NCT02708511
- Acronym / sponsor ID
- GYNOVA0033
- Conditions
- Ovarian Carcinoma, Breast Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sanjiv Sam GambhirUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Cu 64 DOTA-B-Fab) | Experimental | Diagnostic Test: Computed Tomography, Drug: Copper Cu 64-DOTA B-Fab, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Diagnostic Test: Positron Emission TomographyPatients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT | Diagnostic test | Diagnostic (Cu 64 DOTA-B-Fab) |
| Copper Cu 64-DOTA B-FabGiven IV | Drug | Diagnostic (Cu 64 DOTA-B-Fab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (Cu 64 DOTA-B-Fab) |
| Pharmacological StudyCorrelative studies | Other | Diagnostic (Cu 64 DOTA-B-Fab) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo PET/CT | Diagnostic test | Diagnostic (Cu 64 DOTA-B-Fab) |
Primary outcome
Biodistribution of copper Cu 64 DOTA-B-Fab
Time frame: 24 hours
Determined from serial imaging correlated with blood and urine samples.
Dosimetry of copper Cu 64 DOTA-B-Fab
Time frame: 120 minutes post-injection
Determined from serial imaging correlated with blood and urine samples.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjiv Gambhir principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography, Copper Cu 64-DOTA B-Fab and Laboratory Biomarker Analysis in people with Ovarian Carcinoma and Breast Carcinoma, run by Sanjiv Sam Gambhir at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of copper Cu 64 DOTA-B-Fab (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.