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Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

ConditionsMultiple MyelomaPlasma Cell Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobert Flavell, MD, PhD

About this trial

This phase I trial tests the safety of \[89Zr\]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. \[89Zr\]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. \[89Zr\]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and \[89Zr\]DFO-YS5 PET scans may improve detection of multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria

At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria

Age >= 18 years

Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)

Disqualifiers

Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen

Individuals who are pregnant or breastfeeding/chestfeeding.

- Breast-feeding/chest-feeding should be discontinued before administration of [89ZR]DFO-YS5.

Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of [89ZR]-DFO-YS5.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zirconium Zr 89-DFO-YS5

    Drug

    Given IV

  • Positron Emission Tomography / Computed Tomography (PET/CT)

    Procedure/Surgery

    Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image

  • Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)

    Procedure/Surgery

    Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.

  • Fludeoxyglucose F-18

    Other intervention

    Given IV

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Cohort A ([89Zr]DFO-YS5, single scanExperimental treatment 4 interventions
Group B: Cohort B ([89Zr]DFO-YS5, multiple scansExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Sensitivity of metastatic lesion

Defined as the rate of lesions with positive uptake when compared against 18F-fluorodeoxyglucose (FDG) PET/computed tomography (CT) positivity. Sensitivity estimated based on lesion level without considering the location of the lesions or the possible intracorrelation of the lesions from the same patient by point estimate with its 95% confidence interval.

Time frame
Up to 1 week
2

Median maximum standardized uptake value (SUVmax)

The median and range of standardized uptake value maximum (SUVmax) (across all metastatic lesions per participant) in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.

Time frame
Up to 1 week
3

Median Standardized Uptake Value averaged across lesions (SUVmax-avg)

The median and range of SUVmax-average across all lesions in each study cohort will be descriptively reported using mediastinal blood pool and normal organ background uptake values.

Time frame
Up to 1 week

Secondary outcomes

1

Proportion of participants reporting treatment-related Adverse Events

Will be reported descriptively using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 35 days
2

Average organ uptake of [89Zr]DFO-YS5

Regions of interest will be drawn on major organs, and the SUVmax calculated for each patient. Average organ uptake reported with descriptive statistics, including the mean and standard deviation (SD).

Time frame
Up to 1 week
3

Descriptive patterns of intra-tumoral uptake of [89Zr]DFO-YS5

On whole body PET, site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal. The median and range for intra-tumoral SUVmax within metastatic lesions will be reported descriptively on a per-lesion basis to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.

Time frame
Up to 1 week
4

Dosimetry measurements (Cohort B only)

Dosimetry calculations will be performed and reported in millisievert (mSv)/megabecquerels (MBq) on a per-patient basis. Time-activity curves will be generated for each organ, and curve-fitting will be performed to derive the time-integrated activity coefficients

Time frame
Up to 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Flavell, MD, PhD

Lead sponsor

University of California, San Francisco

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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