Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

• Registration Number: NCT00613847
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-12
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab	Patients with invasive solid tumors
2	PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab	Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.

Primary Outcome Measures

Name	Time	Method
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)	conclusion of study

Secondary Outcome Measures

Name	Time	Method
An exploratory objective will be to serially determine tumor uptake of 68Ga-F(ab')2-trastuzumab fragments in a subset of patients with positive scans.	conclusion of study
determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments.	conclusion of study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States