PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
This study is currently recruiting participants.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01269593
First received: December 29, 2010
Last updated: February 15, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin's Lymphoma Active Solid Malignancy |
Drug: PET Imaging using 124 IPUH71 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- To study the pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]of 124I-PUH71 in patients with active solid malignancy and/or lymphoma.
Secondary Outcome Measures:
- To study the metabolism [ Time Frame: 2 years ] [ Designated as safety issue: No ]of 124I-PUH71 in patients with active solid malignancy and/or lymphoma.
- To study the biodistribution [ Time Frame: 2 years ] [ Designated as safety issue: No ]of 124I-PUH71 in patients with active solid malignancy and/or lymphoma.
- To study the radiation dosimetry [ Time Frame: 2 years ] [ Designated as safety issue: No ]of 124I-PUH71 in patients with active solid malignancy and/or lymphoma.
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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 3-4 hours, 20-24 hours, 40-80 hours and (optionally, in willing patients) 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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with solid malignancy and/or lymphoma (current or past) history of histologically-confirmed (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.
- 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.)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269593
Contacts
| Contact: Mark Dunphy, DO | 212-639-8131 | |
| Contact: Gabriela Chiosis, PhD | 646-888-2235 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Mark Dunphy, DO 212-639-8131 | |
| Contact: Gabriela Chiosis, PhD 646-888-2235 | |
| Principal Investigator: Mark Dunphy, DO | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Mark Dunphy, DO | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01269593 History of Changes |
| Other Study ID Numbers: | 10-139 |
| Study First Received: | December 29, 2010 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
PET Scan 124I-PUH71 10-139 |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013