64Cu-LLP2A for Imaging Multiple Myeloma

Last updated: November 8, 2024
Sponsor: Washington University School of Medicine
Overall Status: Terminated

Phase

1

Condition

Multiple Myeloma

Bone Neoplasm

Leukemia

Treatment

PET/CT

64Cu-LLP2A

Blood samples for metabolite analysis

Clinical Study ID

NCT03804424
201807197
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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). 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients 18 years of age or older with clinically or pathologically defined MMin 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 andpreviously treated provided plans are to start a new treatment or restart a priortreatment.

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

  • Able to give informed consent.

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

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

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

Exclusion

Exclusion Criteria:

  • Patients with other invasive malignancies, with the exception of non-melanoma skincancer, who had (or have) any evidence of the other cancer present within the last 5years.

  • Unable to tolerate up to 90 min of PET/MR or PET/CT imaging per imaging session.

Study Design

Total Participants: 10
Treatment Group(s): 8
Primary Treatment: PET/CT
Phase: 1
Study Start date:
November 20, 2018
Estimated Completion Date:
October 01, 2021

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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