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18F-Fluciclovine PET/CT Scan for Multiple Myeloma

Q: Is the eligibility for this trial restricted to adults under sixty years of age?

This research trial is available to volunteers aged 18 and above but no older than 120 years.

Q: Is this research open to all individuals, or are there specific criteria for participation?

For entry into this clinical trial, those affected with <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a> and aged between 18 to 120 are welcome. The total recruitment goal is 55 individuals.

Q: Are there still available positions for participants within this experiment?

According to clinicaltrials.gov, this particular trial is no longer recruiting patients; the research was initially posted on November 1st 2023 and finalized on October 26th 2023. Despite not actively searching for new participants, there are 823 other trials in need of volunteers at present.

Q: What hazards might accompany 18F-fluciclovine PET/CT treatments of Multiple Myeloma sufferers?

Due to the lack of clinical data supporting 18F-fluciclovine PET/CT's efficacy, it was scored with a 2 for safety on our team at Power's scale. This is because Phase 2 trials can indicate some information regarding safety but not effectiveness.

Phase 2

Recruiting

Led By Elizabeth M Hill, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age >=18 years

ECOG performance status <= 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time at each 18f-fluciclovine dose through 3 days after each dose.

Awards & highlights

Study Summary

This trial will test if a new imaging scan is better at detecting MM than the one currently used. Participants will have 3 study visits spread over 5 yrs.

Who is the study for?

Adults over 18 with Multiple Myeloma (MM), either newly diagnosed or having relapsed after treatment, can join this trial. They must have measurable disease and be in relatively good health (ECOG <=2). Women who can bear children and men must use contraception. People with severe allergies to the study drugs, uncontrollable claustrophobia, serious illnesses that could affect participation, or breastfeeding mothers cannot participate.Check my eligibility

What is being tested?

The trial is testing if a new imaging agent called 18F-fluciclovine is better at detecting MM than the current standard agent, 18F-FDG. Participants will undergo PET/CT scans using both agents and may also have an MRI scan and bone marrow biopsy. The tests are spread out over three visits within five years or until disease progression.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the injected substances used for imaging (18F-FDG or 18F-fluciclovine) which might cause symptoms like rash or difficulty breathing. Discomfort from lying still during scans and pain or bruising from needle insertion for biopsies may occur.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have newly diagnosed or previously treated multiple myeloma.

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I have been diagnosed with multiple myeloma according to specific criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time at each 18f-fluciclovine dose through 3 days after each dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time at each 18f-fluciclovine dose through 3 days after each dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time at each 18f-fluciclovine dose through 3 days after each dose. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma.

Secondary outcome measures

Evaluate the ability for 18F-fluciclovine to evaluate response after treatment as compared to the IMWG response criteria.

Evaluate the ability of 18F-fluciclovine to identify minimal residual disease (MRD) as compared to MRD status determined by bone marrow flow cytometry or next generation sequencing (NGS).

Evaluate the efficacy of 18F-fluciclovine in measuring disease volume as compared to other indicators of disease volume such as serum M protein, serum free-light chains, urine M protein, B2 microglobulin, and bone marrow plasma cell percentage.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-fluciclovine PET/CT in Multiple MyelomaExperimental Treatment2 Interventions

Evaluate 18F-fluciclovine PET/CT in participants with multiple myeloma at Timepoint #1, Timepoint #2 ( after induction treatment (NDMM) or six months (RRMM)) and at Timepoint #3 (the time of progression or 5 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FDG PET/CT

2018

N/A

~210

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,386 Total Patients Enrolled

581 Trials studying Multiple Myeloma

189,146 Patients Enrolled for Multiple Myeloma

Elizabeth M Hill, M.D.Principal InvestigatorNational Cancer Institute (NCI)

1 Previous Clinical Trials

59 Total Patients Enrolled

1 Trials studying Multiple Myeloma

59 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Is the eligibility for this trial restricted to adults under sixty years of age?

"This research trial is available to volunteers aged 18 and above but no older than 120 years."

Answered by AI

Is this research open to all individuals, or are there specific criteria for participation?

"For entry into this clinical trial, those affected with multiple myeloma and aged between 18 to 120 are welcome. The total recruitment goal is 55 individuals."

Answered by AI

Are there still available positions for participants within this experiment?

"According to clinicaltrials.gov, this particular trial is no longer recruiting patients; the research was initially posted on November 1st 2023 and finalized on October 26th 2023. Despite not actively searching for new participants, there are 823 other trials in need of volunteers at present."

Answered by AI

What hazards might accompany 18F-fluciclovine PET/CT treatments of Multiple Myeloma sufferers?

"Due to the lack of clinical data supporting 18F-fluciclovine PET/CT's efficacy, it was scored with a 2 for safety on our team at Power's scale. This is because Phase 2 trials can indicate some information regarding safety but not effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

18F-Fluciclovine PET/CT in Multiple Myeloma

2024. "18F-Fluciclovine PET/CT in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103838.