PET Imaging of Patients Using 124I-PU-AD
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 21 - 90 |
| Updated: | 10/28/2017 |
| Start Date: | April 2016 |
| End Date: | August 2018 |
| Contact: | Mark Dunphy, DO |
| Phone: | 212-639-8131 |
PET Imaging of Patients Using 124I-PU-AD: A Pilot Study
The purpose of this study is to help develop a special PET/CT scan to help the investigator
to develop a new drug and see where this drug goes in the body and how long it stays in
diseased and normal tissue. The drug is called PU-AD. In this study, the investigators will
give a tiny dose of PU-AD, a dose which they expect to be much too small to affect the
disease. This tiny dose will be labeled with (attached to) a very small amount of radiation
(called Iodine-124 or 124I) so that the investigators can follow where it goes in the body by
using a PET/CT scanner. Doing this will help the investigators figure out how to best give
higher doses of PU-AD to other patients in the future, and will help the investigators see if
this tiny dose of PU-AD with radiation (124I-PU-AD) might be used in the future to detect
disease using a PET/CT scanner.
to develop a new drug and see where this drug goes in the body and how long it stays in
diseased and normal tissue. The drug is called PU-AD. In this study, the investigators will
give a tiny dose of PU-AD, a dose which they expect to be much too small to affect the
disease. This tiny dose will be labeled with (attached to) a very small amount of radiation
(called Iodine-124 or 124I) so that the investigators can follow where it goes in the body by
using a PET/CT scanner. Doing this will help the investigators figure out how to best give
higher doses of PU-AD to other patients in the future, and will help the investigators see if
this tiny dose of PU-AD with radiation (124I-PU-AD) might be used in the future to detect
disease using a PET/CT scanner.
Inclusion Criteria:
- Age between 21-90 years old.
- Negative serum pregnancy test for females of childbearing age (11-50 years) and/or
lack child-bearing potential.
- No breast-feeding.
- Patients with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial
eligibility criteria as specified below for either disease.
- For cancer patients:
- Patients with eligible histologic type of cancer. Eligible histologic types of
cancer types include solid malignancy, myeloma, and lymphoma.
- Cancer histology confirmed by MSKCC Department of Pathology.
- Cancerous disease is radiologically-measurable or evaluable as defined by
published tumor response criteria (including but not limited to RECIST 1.1).
- For Alzheimer's Disease patients:
- Established diagnosis of mild-moderate Alzheimer's disease based upon
neurological and neuropsychological evaluation following the National Institute
on Aging - Alzheimer's disease Association criteria that recently revisited the
NINCDS-ADRDA criteria. Citation: PMID: 21514250
- Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by
board-certified neurologist (MSKCC or non-MSKCC)
- Patient has an appointed health care proxy specifically designated for research
consent and that this appointment is documented.
- Patient has designated at-home caregiver(s) responsible for providing daily
medications to the patient, who will document the patient's daily doses of SSKI
oral medication, for 2 weeks as per study protocol.
- For patients who have both cancer and Alzheimer's Disease, patients are considered
eligible if they meet all eligibility requirements for either Alzheimer's Disease or
cancer patients, as specified above.
Exclusion Criteria:
- Previous allergic reaction to X-ray CT iodinated 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
- Acute major illness (e.g., unstable cardiovascular condition.)
- Patient inability to give consent personally or via appointed health care proxy
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Mark Dunphy, DO
Phone: 212-639-8131
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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