Actively Recruiting
Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
Led by Washington University School of Medicine · Updated on 2025-07-31
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new formulation of 64Cu-LLP2A, a drug used with PET/CT imaging, to study its dosimetry and imaging quality in healthy volunteers and patients with certain blood cancers. These cancers include multiple myeloma and various low-grade lymphomas. This early phase 1 study aims to confirm that the new formulation provides similar human dosimetry to previously published results and to expand evaluation to patients with confirmed diagnoses or those post bone marrow transplant with suspected recurrence. Participants will receive 64Cu-LLP2A followed by PET/CT imaging at up to three separate times depending on the injection day of the week. Imaging sessions involve multiple quick body scans within the first hour, additional scans between 120 to 240 minutes, and a later scan 15 to 28 hours post injection. Patients with known lesions will have dynamic imaging centered over those areas for one hour, plus an additional scan from head to upper thigh after injection. During the study, participants will undergo PET/CT scans and monitoring of organ dosimetry and safety for up to seven days after 64Cu-LLP2A administration. Researchers will assess the quality of PET images by looking at bone marrow uptake and tumor-to-background ratios. Safety will be tracked by recording any adverse events. The total imaging and evaluation period is estimated to last up to two days, with additional follow-up phone assessments.
CONDITIONS
Brief Title
64Cu-LLP2A for Imaging Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Able to give informed consent
- Able to understand and willing to follow study procedures
- Capable of lying still on their back in a PET/CT scanner for up to 75 minutes
- No illicit or inhaled drug use within the past year by self-report
- No history of claustrophobia or conditions interfering with imaging completion
- Not currently pregnant or nursing; must be surgically sterile, post-menopausal, or have a negative pregnancy test within 24 hours before drug administration
- For patients: Clinical or pathological diagnosis of multiple myeloma or low-grade lymphoma, including follicular, marginal zone, lymphoplasmacytic, or small lymphocytic lymphoma/chronic lymphocytic leukemia
- Patients may be newly diagnosed, relapsed, refractory, or post bone marrow transplant with negative imaging and suspected recurrence
- Patients in other investigational imaging or therapeutic trials may participate
You will not qualify if you...
- History of claustrophobia or other conditions preventing completion of imaging sessions
- Current pregnancy or nursing without surgical sterilization, post-menopausal status, or negative pregnancy test
- Illicit or inhaled drug use within the past year
- Inability to lie still and supine during PET/CT imaging up to 75 minutes
- Unable or unwilling to give informed consent or follow study procedures properly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 days
Participants undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points to evaluate hematologic malignancies and calculate human dosimetry.
Up to 3 imaging visits (in-person) depending on cohort and injection day
Duration - Up to 7 days
Participants are monitored for safety and tolerability of 64Cu-LLP2A through phone call assessments.
Phone call assessments
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
F
Farrokh Dehdashti, M.D.
J
Jennifer Frye, CNMT, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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