Expired Study
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New York, New York 10065


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.


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.


Study is Available At:


Original ID:

06-090


NCT ID:

NCT00613847


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan Kettering Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

17


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jorge Carrasquillo, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center

Study Dates

Start Date:October 2006
Completion Date:December 2013
Completion Type:Actual
Primary Completion Date:December 2013
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 23, 2015
First Received Date:January 21, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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 (HERSc
Time Frame:conclusion of study
Safety Issues:True

Study Interventions

Intervention Type:Radiation
Name:PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzum
Description: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 concur
Arm Name:1
Other Name:Patients will also have blood samples drawn prior
Intervention Type:Radiation
Name:PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzum
Description: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
Arm Name:2
Other Name:Patients will also have blood samples drawn prior

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.
Study Arm Type:Active Comparator
Arm Name:1
Description:Patients with invasive solid tumors

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan Kettering Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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