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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab; Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments.	conclusion of study
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 21, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: PET Scan; Invasive Solid Tumors
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab; Radiopharmaceuticals
• Other Study ID Numbers: 06-090