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

Primary Purpose

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

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET Imaging using 124 IPUH71
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Hodgkin's Lymphoma focused on measuring PET Scan, 124I-PUH71, 10-139

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET Imaging Using 124 IPUH71

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To study the metabolism
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
To study the biodistribution
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
To study the radiation dosimetry
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.

Full Information

First Posted
December 29, 2010
Last Updated
January 10, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Samus Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01269593
Brief Title
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Official Title
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Samus Therapeutics

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Myeloma, Active Solid Malignancy
Keywords
PET Scan, 124I-PUH71, 10-139

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET Imaging Using 124 IPUH71
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PET Imaging using 124 IPUH71
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
To study the pharmacokinetics
Description
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To study the metabolism
Description
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Time Frame
2 years
Title
To study the biodistribution
Description
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Time Frame
2 years
Title
To study the radiation dosimetry
Description
of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm myeloma and/or lymphoma.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Dunphy, DO
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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