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


N/A
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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 (HERScan)

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Jorge Carrasquillo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-090

NCT ID:

NCT00613847

Start Date:

October 2006

Completion Date:

October 2014

Related Keywords:

  • Solid Tumors
  • PET Scan
  • Invasive Solid Tumors

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021