Imaging hematologic malignancies using 64Cu-LLP2A
Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
This study is testing a new imaging agent to see if it can help find blood cancers like multiple myeloma and lymphomas in patients and healthy volunteers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06636175 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new imaging agent, 64Cu-LLP2A, in healthy volunteers and patients with hematologic malignancies such as multiple myeloma and low-grade lymphomas. The study aims to confirm that the new formulation provides comparable human dosimetry to previous findings. It will also include patients who have undergone bone marrow transplants and have negative imaging but are suspected of recurrence. The methodology involves PET/CT imaging to assess the effectiveness of the agent in detecting malignancies.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with multiple myeloma or low-grade lymphomas, particularly those who have had a bone marrow transplant and are experiencing suspected recurrence.
Not a fit: Patients with conditions unrelated to hematologic malignancies or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of imaging for hematologic malignancies, leading to better diagnosis and treatment planning.
How similar studies have performed: Other studies using similar imaging approaches have shown promise, but this specific formulation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Healthy Volunteer: * Adult 18 years of age or older * Able to give informed consent. * Able to comprehend and willing to follow instructions for study procedures as called for by the protocol * Capable of lying still and supine within the PET/CT scanner for up to 75 minutes. * No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms. * No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions. * 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. Inclusion Criteria Hematological Malignancy: * Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease: * Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria * Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia * Adult 18 years of age or older and able to provide informed consent * Capable of lying still and supine within the PET/CT scanner for up to 75 minutes. * No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions * 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 * Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Farrokh Dehdashti, M.D. — Washington University School of Medicine
- Study coordinator: Farrokh Dehdashti, M.D.
- Email: dehdashtif@wustl.edu
- Phone: 314-362-1474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.