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Completed

NCT Number: NCT00613847

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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)

    Time frame: conclusion of study

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2008
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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