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

Purpose

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.

Condition	Intervention
Solid Tumors	Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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) [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Patients with invasive solid tumors	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. Other Names: Patients will also have blood samples drawn prior to infusion and if possible, approximately at 5, 10, 30, 60 minutes and 3-6 hours after 68Ga-DOTA-trastuzumab F(ab')2 infusion. To assess for in-vivo stability of the radiopharmaceutical if possible, HPLC will be performed.
Active Comparator: 2 Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.	Radiation: 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. Other Names: Patients will also have blood samples drawn prior to infusion and if possible, approximately at 5, 10, 30, 60 minutes and 3-6 hours after 68Ga-DOTA-trastuzumab F(ab')2 infusion. To assess for in-vivo stability of the radiopharmaceutical if possible, HPLC will be performed.

Arms

Assigned Interventions

Active Comparator: 1

Patients with invasive solid tumors

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.

Other Names:

Patients will also have blood samples drawn prior to infusion and if possible,
approximately at 5, 10, 30, 60 minutes and 3-6 hours after 68Ga-DOTA-trastuzumab
F(ab')2 infusion. To assess for in-vivo stability of the radiopharmaceutical if possible,
HPLC will be performed.

Active Comparator: 2

Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.

Radiation: 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.

Other Names:

Patients will also have blood samples drawn prior to infusion and if possible,
approximately at 5, 10, 30, 60 minutes and 3-6 hours after 68Ga-DOTA-trastuzumab
F(ab')2 infusion. To assess for in-vivo stability of the radiopharmaceutical if possible,
HPLC will be performed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613847

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Jorge Carrasquillo, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00613847 History of Changes
Other Study ID Numbers:	06-090
Study First Received:	January 21, 2008
Last Updated:	March 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

PET Scan
Invasive Solid Tumors

Additional relevant MeSH terms:

Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013