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Active, not recruitingNCT01269593Updated Jan 15, 2026

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

An Early Phase 1 interventional study of PET Imaging using 124 IPUH71 in Non-Hodgkin's Lymphoma, Myeloma and Active Solid Malignancy, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Memorial Sloan Kettering Cancer Center · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Non-Hodgkin's Lymphoma
  • Myeloma
  • Active Solid Malignancy

Keywords

  • PET Scan
  • 124I-PUH71
  • 10-139
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In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 63 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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.)
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • 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

Interventions

  • DrugPET 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.

    Also known as: 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.

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What researchers measure

Primary outcomes

  1. To study the pharmacokinetics

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

    Time frame: 2 years

Secondary outcomes

  1. To study the metabolism

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

    Time frame: 2 years

  2. To study the biodistribution

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

    Time frame: 2 years

  3. To study the radiation dosimetry

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

    Time frame: 2 years

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Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01269593
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Samus Therapeutics
Responsible party
Sponsor
First posted
Jan 4, 2011
Start date
Dec 2010
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 15, 2026

Study contacts

Mark Dunphy, DO
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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