Back to results

PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer (Cu-64 HER2+)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PET Imaging With Cu-64 Labeled Trastuzumab

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Cu-64 LABELED TRASTUZUMAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Registered patient at MSKCC
Age ≥18 years
Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
Measurable or evaluable disease
Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
Karnofsky Performance Score ≥ 60
Signed informed consent

Exclusion Criteria:

Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
Claustrophobia/pain 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.
Inability to provide written informed consent.
Patients with liver metastases as the only site of distant disease
Patients with known sensitivity or contraindication to Herceptin.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.

breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies

Outcomes

Primary Outcome Measures

test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab

Secondary Outcome Measures

to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer.

to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.

Full Information

NCT ID

NCT00605397

First Posted

January 18, 2008

Last Updated

December 23, 2015

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00605397

Brief Title

PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

Acronym

Cu-64 HER2+

Official Title

Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Cu-64 LABELED TRASTUZUMAB

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.

Arm Title

Arm Type

Experimental

Arm Description

breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies

Intervention Type

Radiation

Intervention Name(s)

PET Imaging With Cu-64 Labeled Trastuzumab

Intervention Description

The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.

Intervention Type

Radiation

Intervention Name(s)

PET Imaging With Cu-64 Labeled Trastuzumab

Intervention Description

The remaining 20 patients will undergo one PET study.

Primary Outcome Measure Information:

Title

test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab

Time Frame

conclusion of study

Secondary Outcome Measure Information:

Title

to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer.

Time Frame

conclusion of study

Title

to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer.

Time Frame

conclusion of study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Registered patient at MSKCC Age ≥18 years Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH)) Measurable or evaluable disease Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care Karnofsky Performance Score ≥ 60 Signed informed consent Exclusion Criteria: Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy Claustrophobia/pain 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. Inability to provide written informed consent. Patients with liver metastases as the only site of distant disease Patients with known sensitivity or contraindication to Herceptin.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Carrasquillo, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

We'll reach out to this number within 24 hrs