64Cu-LLP2A for Imaging Hematologic Malignancies

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06636175
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 64Cu-LLP2A — DRUG
    64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
  • PET/CT — DEVICE
    The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating oncologist/surgeon unless, in the judgment of the principal investigator, the images demonstrate an unsuspected abnormality that may warrant further evaluation.

Study Details

This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.

Key Dates

Start date
Feb 26, 2025
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
    \- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs: * Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan * Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan * ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)
  • Experimental: Cohort 2B: Quantitative 64Cu-LLP2A
    \- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.

Primary Outcome Measure

Organ dosimetry of participants [ Time Frame: Through completion of PET/CT scans (estimated to be up to 2 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Farrokh Dehdashti, M.D.
[email protected]
314-362-1474
Jennifer Frye, CNMT, CCRC
[email protected]
314-747-1604
Farrokh Dehdashti, M.D. (PRINCIPAL_INVESTIGATOR)
Ravi Vij, M.D. (SUB_INVESTIGATOR)
Keith Stockerl-Goldstein, M.D. (SUB_INVESTIGATOR)
Amanda Cashen, M.D. (SUB_INVESTIGATOR)
Mark A Schroeder, M.D. (SUB_INVESTIGATOR)
Armin Ghobadi, M.D. (SUB_INVESTIGATOR)
Fei Wan, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Washington University School of Medicine· St Louis, MO

Related Studies