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PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study


N/A
18 Years
90 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Active Solid Malignancy

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Trial Information

PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study


Inclusion Criteria:



- Patients with solid malignancy and/or lymphoma (current or past) history of
histologically-confirmed (histology confirmed by MSKCC Department of Pathology.)

- Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or
other tumor response criteria from an MSKCC IRB-approved clinical research protocol.

- Age between 18-90

- Negative serum pregnancy test for females of childbearing age (11-55 years) and/or
lack child-bearing potential

- No breast-feeding

Exclusion Criteria:

- Previous allergic reaction to contrast medium.

- Hypersensitivity to iodide products.

- Known hyperthyroidism

Hepatic:

- Bilirubin > 1.5 x institutional upper limit of normal (ULN)

- AST/ALT >2.5 x ULN

- Albumin < 2 g/dl

- GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN. Renal: Creatinine >1.5 x ULN or
creatinine clearance < 60 mL/min.

- Positive serum pregnancy test for females

- Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To study the pharmacokinetics

Outcome Description:

of 124I-PUH71 in patients with active solid malignancy and/or lymphoma.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mark Dunphy, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-139

NCT ID:

NCT01269593

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Active Solid Malignancy
  • PET Scan
  • 124I-PUH71
  • 10-139
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021