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

NCT00613847 | Completed Phase 1

• 1 other identifier: 06-090
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Keywords

PET Scan; Invasive Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Patients with invasive solid tumors

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

2

ACTIVE COMPARATOR

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

Interventions

PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab RADIATION

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.

Also known as: 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jorge Carrasquillo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 13, 2008
• Study Start: October 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 26, 2020

Record last verified: 2015-12

Locations

US (1)