Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892393
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-05-26
Brief Title:
Imaging Study of 89ZrDFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Sponsor:
Robert Flavell MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot PET Imaging Study of 89ZrDFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety of 89ZrDFO-YS5 positron emission tomography PET imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma 89ZrDFO-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 89ZrDFO-YS5 targets a specialized protein called CD46 which is in certain multiple myeloma cancer cells and 89ZrDFO-YS5 PET scans may improve detection of multiple myeloma
Detailed Description:
PRIMARY OBJECTIVE
I To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 89ZrDFO-YS5 PET as compared with fludeoxyglucose F-18 18F-FDG PET imaging
SECONDARY OBJECTIVES
I To determine the safety of 89ZrDFO-YS5 II To determine the average organ uptake of 89ZrDFO-YS5 III To descriptively report the patterns of intra-tumoral uptake of 89ZrDFO-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 89ZrDFO-YS5 in patients with multiple myeloma
EXPLORATORY OBJECTIVE
I To determine the association between uptake standardized uptake value maximum SUVmax of 89ZrDFO-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 89ZrDFO-YS5 intravenously IV and undergo a single PETCT or PETMRI scan 5-7 days post-injection Participants also receive fludeoxyglucose F-18 IV and undergo PETCT or PETMRI scan within 28 days prior to day 1
COHORT B Participants receive 89ZrDFO-YS5 IV and undergo four PETCT or PETMRI scans on days 1 2 3-4 and 5-7 post-injection Participants also receive fludeoxyglucose F-18 IV and undergo PETCT or PETMRI scan within 28 days prior to day 1
Patients are followed up at 30 days after final scan
I To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 89ZrDFO-YS5 PET as compared with fludeoxyglucose F-18 18F-FDG PET imaging
SECONDARY OBJECTIVES
I To determine the safety of 89ZrDFO-YS5 II To determine the average organ uptake of 89ZrDFO-YS5 III To descriptively report the patterns of intra-tumoral uptake of 89ZrDFO-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 89ZrDFO-YS5 in patients with multiple myeloma
EXPLORATORY OBJECTIVE
I To determine the association between uptake standardized uptake value maximum SUVmax of 89ZrDFO-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 89ZrDFO-YS5 intravenously IV and undergo a single PETCT or PETMRI scan 5-7 days post-injection Participants also receive fludeoxyglucose F-18 IV and undergo PETCT or PETMRI scan within 28 days prior to day 1
COHORT B Participants receive 89ZrDFO-YS5 IV and undergo four PETCT or PETMRI scans on days 1 2 3-4 and 5-7 post-injection Participants also receive fludeoxyglucose F-18 IV and undergo PETCT or PETMRI scan within 28 days prior to day 1
Patients are followed up at 30 days after final scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04068 | REGISTRY | None | None |
| R01CA271606 | NIH | NCI Clinical Trials Reporting Program CTRP | httpsreporternihgovquickSearchR01CA271606 |