PET Imaging of Patients Using 124I-PU-AD

Last updated: October 25, 2017
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alzheimer's Disease

Memory Loss

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT02751554
16-004
  • Ages 21-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 21-90 years old.

  • Negative serum pregnancy test for females of childbearing age (11-50 years) and/orlack child-bearing potential.

  • No breast-feeding.

  • Patients with a diagnosis of cancer and/or Alzheimer's Disease, meeting trialeligibility criteria as specified below for either disease.

  • For cancer patients:

  • Patients with eligible histologic type of cancer. Eligible histologic types ofcancer types include solid malignancy, myeloma, and lymphoma.

  • Cancer histology confirmed by MSKCC Department of Pathology.

  • Cancerous disease is radiologically-measurable or evaluable as defined bypublished 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 uponneurological and neuropsychological evaluation following the National Instituteon Aging - Alzheimer's disease Association criteria that recently revisited theNINCDS-ADRDA criteria. Citation: PMID: 21514250

  • Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, byboard-certified neurologist (MSKCC or non-MSKCC)

  • Patient has an appointed health care proxy specifically designated for researchconsent and that this appointment is documented.

  • Patient has designated at-home caregiver(s) responsible for providing dailymedications to the patient, who will document the patient's daily doses of SSKIoral medication, for 2 weeks as per study protocol.

  • For patients who have both cancer and Alzheimer's Disease, patients are consideredeligible if they meet all eligibility requirements for either Alzheimer's Disease orcancer patients, as specified above.

Exclusion

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

Study Design

Total Participants: 10
Study Start date:
April 01, 2016
Estimated Completion Date:
August 31, 2018

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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