Clinical trial · Interventional
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
NCT01269593CI-TRIAL-00100927active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Active Solid Malignancy | Plasma Cell Neoplasm | PROBABILISTIC | 0.70 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET Imaging using 124 IPUH71 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET Imaging Using 124 IPUH71
- 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.
- interventionNames
- Drug: PET Imaging using 124 IPUH71
Primary outcomes (1)
- measure
- To study the pharmacokinetics
- timeFrame
- 2 years
- description
- of 124I-PUH71 in patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma.
Secondary outcomes (3)
- measure
- To study the metabolism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.