Clinical trial · Interventional
Imaging With a New Agent That Finds a Cancer Protein Called HER2
First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
NCT03109977CI-TRIAL-00032538completedPhase 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)
The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.
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 |
|---|---|---|---|
| HER2-positive Carcinoma | — | UNRESOLVED | — |
| HER2-positive Primary Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zr-DFO-pertuzumab PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT
- description
- Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited.
- interventionNames
- Drug: Zr-DFO-pertuzumab PET/CT
Primary outcomes (1)
- measure
- Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0
- timeFrame
- 1 year
- description
- Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21 years or greater * Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate. * At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment * ECOG performance of 0-2 Exclusion Criteria: * Life expectancy \< 3 months * Pregnancy or lactation * Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
References
Publications (0)
Data not yet available
No reference posted for this study.