Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine for Brain Tumor

Huntsman Cancer Institute, Salt Lake City, UT
Brain TumorMulti-tracer PET exams of [18F]FLT and [18F]Fluciclovine - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing whether two PET imaging agents can better predict tumor response and overall survival than MRI in patients with high-grade brain tumors.

Eligible Conditions
  • Brain Tumor

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 years

2 years
Increased Overall Survival
More predictive of overall survival than an MRI
More predictive of time to progression than an MRI
Month 6
Ability of [18F]FLT and/or [18F]Fluciclovine alone or together to predict true progression from pseudoprogression
Month 6
Association between overall survival and quantitative markers
Association between progression free survival and quantitative markers

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

All Enrolled participants
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine · No Placebo Group · Phase 2

All Enrolled participants
Drug
Experimental Group · 1 Intervention: Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

University of UtahLead Sponsor
1,022 Previous Clinical Trials
1,776,345 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
29 Previous Clinical Trials
2,692 Total Patients Enrolled
John Hoffman, MDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
17 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What is the total number of participants in this clinical research experiment?

"Affirmative. Records present on clinicaltrials.gov demonstrate that this medical trial is currently enlisting individuals; it was initially advertised in September 24th 2018, and the details were most recently updated October 6th 2022. The study demands 30 participants from a single location." - Anonymous Online Contributor

Unverified Answer

Are any new participants still eligible for this investigation?

"Yes, the current data on clinicaltrials.gov shows that this experiment is actively recruiting participants. It was initially posted in September 2018 and revised most recently in October 2022, with a need for 30 individuals across one medical centre." - Anonymous Online Contributor

Unverified Answer

Are there any records of experiments in which the imaging techniques [18F]FLT and [18F]Fluciclovine have been utilized together?

"At the moment, 4 active clinical trials are researching Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine with zero currently in Phase 3. These studies have been established across three different locations, one of which is Pittsburgh, Pennsylvania." - Anonymous Online Contributor

Unverified Answer

Is this the inaugural iteration of this particular clinical research?

"Since 2018, Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine have been investigated by Blue Earth Diagnostics. After the initial study with 30 participants in 2018, Phase 2 drug approval was granted for this product. Currently, there are 4 active studies on this topic taking place across 3 cities and 1 country." - Anonymous Online Contributor

Unverified Answer

Has the US Food and Drug Administration granted approval for Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine?

"Considering the lack of data validating its efficacy, Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine have been assigned a score of 2 on Power's safety scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.