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PET Imaging with 124I-PUH71 for Cancer

Phase < 1
Waitlist Available
Led By Mark Dunphy, DO
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing how a new drug, PUH71, reacts in the body and how long it lasts in the blood. The results will help researchers plan how to use PUH71 as a new cancer treatment and if it can be used to detect tumors.

Who is the study for?
This trial is for adults aged 18-90 with certain types of cancer, including solid tumors, myeloma, and lymphomas that can be measured or evaluated. Women must not be pregnant or breastfeeding. Participants should not have had allergic reactions to contrast media, iodide hypersensitivity, hyperthyroidism, significant kidney or liver issues, or acute major illnesses.
What is being tested?
Researchers are testing a new drug called PUH71 using PET imaging to see how it distributes in the body and tumors and its duration in the blood. This will inform future high-dose trials for cancer treatment and potential use in tumor detection.
What are the potential side effects?
Potential side effects aren't detailed but may include typical reactions related to PET imaging agents such as mild irritation at injection site or allergic reaction due to sensitivity towards iodide-based compounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or unable to become pregnant.
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My cancer type has been confirmed by pathology.
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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an overactive thyroid.
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My liver function tests are within the trial's required ranges.
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My kidney function is reduced, with creatinine levels high or clearance low.
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I do not have any severe illnesses like infections or heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To study the pharmacokinetics
Secondary study objectives
To study the biodistribution
To study the metabolism
To study the radiation dosimetry

Trial Design

1Treatment groups
Experimental Treatment
Group I: PET Imaging Using 124 IPUH71Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Samus TherapeuticsUNKNOWN
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,493 Total Patients Enrolled
Mark Dunphy, DOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

PET Imaging using 124 IPUH71 Clinical Trial Eligibility Overview. Trial Name: NCT01269593 — Phase < 1
Non-Hodgkin's Lymphoma Research Study Groups: PET Imaging Using 124 IPUH71
Non-Hodgkin's Lymphoma Clinical Trial 2023: PET Imaging using 124 IPUH71 Highlights & Side Effects. Trial Name: NCT01269593 — Phase < 1
PET Imaging using 124 IPUH71 2023 Treatment Timeline for Medical Study. Trial Name: NCT01269593 — Phase < 1
~1 spots leftby Dec 2024
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