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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01269593
• Other study ID #: 10-139
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: December 2010
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Samus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the pharmacokinetics	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.	2 years
Secondary	To study the metabolism	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years
Secondary	To study the biodistribution	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years
Secondary	To study the radiation dosimetry	of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center