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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01269593
Collaborator
Samus Therapeutics (Other)
63
Enrollment
1
Location
1
Arm
144
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.

Condition or Disease Intervention/Treatment Phase
  • Drug: PET Imaging using 124 IPUH71
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Actual Study Start Date :
Dec 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PET Imaging Using 124 IPUH71

Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients.

Drug: PET Imaging using 124 IPUH71
A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. A 30-45 minute scanning timeperiod is typical for clinical PET studies.
Other Names:
  • Blood will be drawn at the multiple time points for pharmacokinetic & metabolite
  • analyses of 124I-PUH71. We anticipate these time points to be: approximately 10
  • minutes, 20 minutes, 30 minutes, 1-2 H, and 3-4 H, post-injection. Blood
  • samples will be obtained in the PET imaging suite.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To study the pharmacokinetics [2 years]

      of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.

    Secondary Outcome Measures

    1. To study the metabolism [2 years]

      of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.

    2. To study the biodistribution [2 years]

      of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.

    3. To study the radiation dosimetry [2 years]

      of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (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.

    • This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).

    • 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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • Samus Therapeutics

    Investigators

    • Principal Investigator: Mark Dunphy, DO, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01269593
    Other Study ID Numbers:
    • 10-139
    First Posted:
    Jan 4, 2011
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Memorial Sloan Kettering Cancer Center
    PET Scan
    124I-PUH71
    10-139
    Additional relevant MeSH terms:
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of Nov 22, 2021