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NCT Number: NCT01269593

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-Hodgkin's Lymphoma Active Solid Malignancy Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early 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

  • 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.)

Treatment and study plan

PET Imaging using 124 IPUH71

Drug

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.

Primary outcomes

  1. To study the pharmacokinetics

    Time frame: 2 years

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

Secondary outcomes

  1. To study the metabolism

    Time frame: 2 years

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

  2. To study the biodistribution

    Time frame: 2 years

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

  3. To study the radiation dosimetry

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Samus Therapeutics

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Jan 4, 2011
Registry last updated
Jan 15, 2026

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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