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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met