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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-04068 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| R01CA271606 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVE:
I. To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 ([89Zr]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.
SECONDARY OBJECTIVES:
I. To determine the safety of [89Zr]DFO-YS5. II. To determine the average organ uptake of [89Zr]DFO-YS5. III. To descriptively report the patterns of intra-tumoral uptake of [89Zr]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.
IV. To calculate the dosimetry of [89Zr]DFO-YS5 in patients with multiple myeloma.
EXPLORATORY OBJECTIVE:
I. To determine the association between uptake (standardized uptake value maximum [SUVmax]) of [89Zr]DFO-YS5 with 1q amplification by fluorescence in situ hybridization (FISH) on tumor biopsies (when available; FISH may be conducted as part of routine, standard-of-care).
OUTLINE: Participants are assigned to 1 of 2 cohorts based on participant preference.
COHORT A: Participants receive [89Zr]DFO-YS5 intravenously (IV) and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.
COHORT B: Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.
Patients are followed up at 30 days after final scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A ([89Zr]DFO-YS5, single scan | Experimental | Participants receive [89Zr]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1 |
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| Cohort B ([89Zr]DFO-YS5, multiple scans | Experimental | Participants receive [89Zr]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zirconium Zr 89-DFO-YS5 | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 week |
| 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. | Up to 1 week |
| 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. | Up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 35 days |
| Average organ uptake of [89Zr]DFO-YS5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Aslam | Contact | (415) 514-8987 | Maya.Aslam@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Flavell, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Positron Emission Tomography / Computed Tomography (PET/CT) | Procedure | 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 |
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| Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) | Procedure | 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. |
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| Fludeoxyglucose F-18 | Other | Given IV |
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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). |
| Up to 1 week |
| 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. | Up to 1 week |
| 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 | Up to 1 week |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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