Clinical trial · Interventional
Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study
NCT02708511CI-TRIAL-00032370terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Diagnostic Test | — | UNRESOLVED |
| Copper Cu 64-DOTA B-Fab | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Positron Emission Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Cu 64 DOTA-B-Fab)
- description
- Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
- interventionNames
- Diagnostic Test: Computed Tomography
- Drug: Copper Cu 64-DOTA B-Fab
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Diagnostic Test: Positron Emission Tomography
Primary outcomes (2)
- measure
- Biodistribution of copper Cu 64 DOTA-B-Fab
- timeFrame
- 24 hours
- description
- Determined from serial imaging correlated with blood and urine samples.
- measure
- Dosimetry of copper Cu 64 DOTA-B-Fab
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.