Clinical Trial

Imaging Multiple Myeloma

Study Description

64Cu-LLP2A for Imaging Multiple Myeloma

The investigators are performing a trial with goals to demonstrate the feasibility of imaging multiple myeloma (MM) patients with 64Cu-LLP2A-positron emission tomography (PET)/magnetic resonance (MR). The investigators suggest that 64Cu-LLP2A will allow for an accurate molecular imaging of MM lesions, which will have an important impact on early stage disease detection and in the long term on the initiation and choice of therapy in these patients.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - 64Cu-LLP2A

-64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)

Device - PET/MR

-All PET imaging will be performed with a Siemens mMR PET/MR scanner

Procedure - Blood samples for serum stability

-3 venous samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (2 mL each) will be obtained at the following time points: Cohort 1: prior to injection, at completion of dynamic scanning in those who undergo dynamic imaging and at completion of one of the body imaging time points. In those who do not undergo dynamic imaging, prior to injection, and after completing body imaging at 2 of the 3 time points. Cohort 2: subjects will have samples drawn prior to injection, at ...read more on ClinicalTrials.org

Procedure - Blood samples for metabolite analysis

-Typically, 2 blood samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (preferably 1 within the first 5 min and 1 at the completion of the first hour of imaging) will be obtained.

Procedure - Urine sample

-Cohort 1 only

Procedure - Tumor biopsy

-Cohort 2 only and only if there hasn't been a recent biopsy of disease

Procedure - Electrocardiogram

-A standard 12-lead ECG will be obtained on all subjects at baseline (within 30 mins prior to injection of 64Cu-LLP2A), and at least 60 minutes post injection or prior to study discharge

Additional Information

Official Study Title

Early Phase I Evaluation of 64Cu-LLP2A for Imaging Multiple Myeloma

Clinical Trial ID

NCT03804424

ParticipAid ID

bDk6Ya