PET Imaging of Patients Using 124I-PU-AD

Multiple Myeloma Clinical Trial

Official title:

PET Imaging of Patients Using 124I-PU-AD: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02751554
• Other study ID #: 16-004
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2016
• Last updated: October 25, 2017
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Mark Dunphy, DO
• Phone: 212-639-8131
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Lymphoma
• Multiple Myeloma
• Solid Malignancy

Intervention

Drug:
• 124I-PU-AD

Device:
• PET Scan

Other:
• Blood draws

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Rockefeller University, Samus Therapeutics, Inc., Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the plasma time activity concentration curves	Blood samples will then be centrifuged and the plasma pipetted, weighed and counted to determine the plasma time activity concentration curves (% injected dose/liter)	2 weeks

External Links

•   Memorial Sloan Kettering Cancer Center