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Radioactive Tracer Imaging for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Robert Flavell, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Creatinine clearance >= 60 mL/min, calculated using the Cockcroft-Gault equation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 35 days

Awards & highlights

Study Summary

This trial tests a new imaging tool to detect multiple myeloma using a radioactive tracer that targets cancer cells.

Who is the study for?

This trial is for adults over 18 with confirmed multiple myeloma, who have at least one lesion visible on PET scans. They must have normal bilirubin levels, a creatinine clearance of >=60 mL/min, and liver enzymes (AST/ALT) within three times the upper limit. Pregnant or breastfeeding individuals are excluded, as well as those unable to follow study procedures.Check my eligibility

What is being tested?

[89Zr]DFO-YS5 PET imaging is being tested for its ability to detect CD46 positive cancer cells in multiple myeloma patients. This phase I trial will assess the safety of this radiopharmaceutical tracer and its effectiveness in improving detection of the disease.See study design

What are the potential side effects?

Potential side effects may include reactions related to the injection of radioactive material such as discomfort at injection site or allergic reactions. Since it's an imaging study, fewer side effects are expected compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show at least one active cancer lesion, more intense than the liver.

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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

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I am 18 years old or older.

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My multiple myeloma diagnosis is confirmed by specific medical criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Median maximum standardized uptake value (SUVmax)

Sensitivity of metastatic lesion

Secondary outcome measures

Average organ uptake of [89Zr]DFO-YS5

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

Dosimetry measurements (Cohort B only)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B ([89Zr]DFO-YS5, multiple scansExperimental Treatment4 Interventions

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

Group II: Cohort A ([89Zr]DFO-YS5, single scanExperimental Treatment4 Interventions

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Robert Flavell, MD, PhDLead Sponsor

3 Previous Clinical Trials

44 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,834 Total Patients Enrolled

579 Trials studying Multiple Myeloma

189,111 Patients Enrolled for Multiple Myeloma

Media Library

Cohort A ([89Zr]DFO-YS5, single scan Clinical Trial Eligibility Overview. Trial Name: NCT05892393 — Phase 1

Multiple Myeloma Research Study Groups: Cohort A ([89Zr]DFO-YS5, single scan, Cohort B ([89Zr]DFO-YS5, multiple scans

Multiple Myeloma Clinical Trial 2023: Cohort A ([89Zr]DFO-YS5, single scan Highlights & Side Effects. Trial Name: NCT05892393 — Phase 1

Cohort A ([89Zr]DFO-YS5, single scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT05892393 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is [89Zr]DFO-YS5, single scan a secure procedure for Cohort A participants?

"The safety of Cohort A ([89Zr]DFO-YS5, single scan) was rated a 1 on Power's scale due to the lack of evidence for efficacy and safety thus far in Phase I research."

Answered by AI

Are there any vacancies open to prospective participants for this clinical trial?

"Sadly, the clinical trial is not presently accepting participants. The posting was originally made on July 1st 2023 and last edited on May 26th of that same year. Nonetheless, there are 833 other trials with open enrollment at this moment in time."

Answered by AI

To what ends is this research endeavor striving?

"This clinical trial, with a duration of up to 1 week, will observe the Median maximum standardized uptake value (SUVmax) as its principal objective. Secondary goals include: calculating Average organ uptake of [89Zr]DFO-YS5 through regions of interest; noting Descriptive patterns of intra-tumoral uptake in terms of signal and interpatient heterogeneity; and Dosimetry measurements for Cohort B patients which records activity coefficients over time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Robert Flavell, MD, PhD 2023. "Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05892393.