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NCT00613847 Clinical Trial

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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00613847
Other study ID # 06-090
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2006
Est. completion date December 2013

Study information
Verified date December 2015
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
• PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments. conclusion of study
Secondary 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
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