64Cu-LLP2A Imaging for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byFarrokh Dehdashti, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Farrokh Dehdashti, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma, including those newly diagnosed or previously treated who are starting new therapy. Participants must be able to consent and have no metal implants that interfere with PET/MR imaging. They should not be pregnant/nursing and have a GFR of at least 60 mg/mL/1.73 m^2 if receiving MRI contrast.

Inclusion Criteria

I am not pregnant or nursing, and cannot become pregnant or am not currently pregnant.

Able to give informed consent.

I am 18 or older and have been diagnosed with multiple myeloma.

See 4 more

Exclusion Criteria

I cannot stay still for up to 90 minutes for a scan.

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

Treatment Details

Interventions

64Cu-LLP2A (Radiopharmaceutical)

Trial OverviewThe trial tests the use of a radioactive tracer called 64Cu-LLP2A in combination with PET/MR imaging to detect multiple myeloma lesions accurately. It aims to improve early disease detection and influence treatment choices by providing better molecular images of cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Quantitative 64Cu-LLP2A ImagingExperimental Treatment7 Interventions

* 20 patients with MM will be recruited * Subjects who enter on study in Cohort 2 will undergo a 60-min dynamic imaging over the known site of disease (OR pelvis and lower lumbar spine, if no site of disease is known). Following a simple DIXON MRI or low dose CT scan for attenuation correction, subjects will be injected with a dose of up to11 mCi of 64Cu-LLP2A and a list mode dynamic imaging acquisition will begin for a total of 60 mins. Following the dynamic study, or at the optimal time point determined from cohort 1 imaging, after a simple DIXON or low dose CT scan for body (top of the head to below the knees) attenuation correction, emission scans (2-5 min per bed position) will be performed

Group II: Cohort 1: Pilot 64Cu-LLP2A ImagingExperimental Treatment7 Interventions

* 16 adult individuals (6-8 patients with known MM; 6-10 healthy volunteers) * All subjects who enter the study in Cohort 1 will be injected with up to 11 mCi of 64Cu-LLP2A and will undergo body imaging at least twice within 0-30 hrs following administration of 64Cu-LLP2A to study tracer biodistribution and calculate human dosimetry * 6 subjects will also undergo dynamic study for 60 mins immediately after administration of 64Cu-LLP2A.