Clinical trial · Interventional
Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab
NCT00613847CI-TRIAL-00047920completedPhase 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 learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Patients with invasive solid tumors
- interventionNames
- Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.
- interventionNames
- Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
Primary outcomes (1)
- measure
- the safety & feasibility of PET imaging with radiolabeled 68Ga-F(ab')2-trastuzumab fragments in pts w invasive solid tumors; by using the organ/tissue & body rt dosimetry inform following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments (HERScan)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Registered patient at MSKCC * Age ≥ or = to 18 years * Patients with invasive solid tumors. * Measurable or evaluable disease * Patients must have had routine disease staging studies with CT scan, FDG PET/CT scan, bone scan and/or MRI within 8 weeks of enrollment onto this trial * Karnofsky Performance Score ≥ or = to 60 * Signed informed consent Exclusion Criteria: * Claustrophobia/pain or any other disability leading to inability to lie still for the duration of the scanning procedure. * Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material. * Patients with known sensitivity or contraindication to Herceptin. * Inability to provide written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.