64Cu-LLP2A for Imaging Multiple Myeloma

The Washington University

Status and phase: Terminated; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Procedure: Blood samples for metabolite analysis; Procedure: Urine sample; Procedure: Blood samples for serum stability; Device: PET/MR; Device: PET/CT; Procedure: Tumor biopsy; Drug: 64Cu-LLP2A; Procedure: Electrocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT03804424

201807197

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients 18 years of age or older with clinically or pathologically defined MM in accordance with International Myeloma Working Group or as stated in office note / clinical assessment from treating physician.

  *All types of active myeloma are eligible including both newly diagnosed and previously treated provided plans are to start a new treatment or restart a prior treatment.

• Healthy Volunteer Subjects: Adult 18 years of age or older with no known hematologic disorder such as anemia, leukemia, etc. who is considered healthy based on assessment by PI. (Cohort 1 only).

• Able to give informed consent.

• Does not have any exclusions related to PET/MR imaging: No implanted medical devices such as: pacemaker, defibrillator, neurostimulator, artificial heart valve, cerebral aneurysm clips, no accidental exposure to metal fragments (if applicable)

• If applicable for administration of contrast with MRI imaging subject must have a calculated GFR of at least 60 mg/mL/1.73 m^2.

• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.

Exclusion criteria

• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years.
• Unable to tolerate up to 90 min of PET/MR or PET/CT imaging per imaging session.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Cohort 1: Pilot 64Cu-LLP2A Imaging

Experimental group

Description:

* 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.

Treatment:

Procedure: Electrocardiogram

Drug: 64Cu-LLP2A

Device: PET/CT

Device: PET/MR

Procedure: Urine sample

Procedure: Blood samples for serum stability

Procedure: Blood samples for metabolite analysis

Cohort 2: Quantitative 64Cu-LLP2A Imaging

Experimental group

Description:

* 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

Treatment:

Procedure: Electrocardiogram

Drug: 64Cu-LLP2A

Procedure: Tumor biopsy

Device: PET/CT

Device: PET/MR

Procedure: Blood samples for serum stability

Procedure: Blood samples for metabolite analysis