64Cu-LLP2A for Imaging Multiple Myeloma

Summary

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.

Conditions

• Multiple Myeloma

Interventions

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 as PET/MR or PET/CT

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 completion of dynamic scanning, and at completion of body imaging.

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

DEVICE

PET/CT

-All PET imaging will be performed as PET/MR or PET/CT

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Farrokh Dehdashti, M.D. · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-20

Primary Completion

2021-10-01

Completion

2021-10-01

FDA Drug

Yes

Countries

• United States

Study Locations