Status:
TERMINATED
64Cu-LLP2A for Imaging Multiple Myeloma
Lead Sponsor:
Washington University School of Medicine
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03804424
Start Date
November 20 2018
End Date
October 1 2021
Last Update
November 12 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110