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Radiopharmaceutical

Fluciclovine PET-Guided Radiotherapy for Glioblastoma

Phase 2
Recruiting
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological diagnosis of primary, newly diagnosed supratentorial, WHO grade IV glioma
Karnofsky performance score greater than 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This triallooks at if PET scans with 18F-fluciclovine can help detect cancer cells and improve radiation therapy to treat prostate cancer. It also looks at if using this scan leads to longer survival and if/where the tumor returns.

Who is the study for?
This trial is for adults over 18 with a new diagnosis of glioblastoma, who've had surgery and are planning standard radiation and chemotherapy. They should have a life expectancy of at least 3 months, be able to undergo MRI/PET scans, not be pregnant or breastfeeding, and have no prior treatments that overlap with this study's methods.Check my eligibility
What is being tested?
The study tests if adding Fluciclovine PET scans to the usual MRI/CT can improve radiation therapy targeting in glioblastoma treatment. It also examines whether this method extends patient survival and where tumors might recur.See study design
What are the potential side effects?
Potential side effects may include reactions to the radioactive diagnostic agent Fluciclovine used during PET scanning or issues related to contrast agents used in imaging procedures like allergies or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a high-grade brain tumor above the cerebellum.
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I am able to care for myself and perform normal activities with minimal assistance.
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I am scheduled for standard therapy with radiation and TMZ after surgery.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Defining Tumor Volume
Patterns of Failure
Secondary outcome measures
Overall survival utilizing MRI+PET radiotherapy
Progression free survival utilizing MRI+PET-based radiotherapy
Survival using MRI radiotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MRI + Fluciclovine PET-guided radiotherapyExperimental Treatment1 Intervention
Patients will undergo MRI + Fluciclovine PET-guided radiotherapy
Group II: MRI-guided radiotherapyActive Control1 Intervention
Patients will undergo standard of care MRI-guided radiotherapy.

Find a Location

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,887 Total Patients Enrolled
1 Trials studying Glioblastoma
30 Patients Enrolled for Glioblastoma
Arizona Biomedical Research Commission (ABRC)OTHER
2 Previous Clinical Trials
105 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,605 Total Patients Enrolled
6 Trials studying Glioblastoma
231 Patients Enrolled for Glioblastoma

Media Library

Fluciclovine PET (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04840069 — Phase 2
Glioblastoma Research Study Groups: MRI-guided radiotherapy, MRI + Fluciclovine PET-guided radiotherapy
Glioblastoma Clinical Trial 2023: Fluciclovine PET Highlights & Side Effects. Trial Name: NCT04840069 — Phase 2
Fluciclovine PET (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840069 — Phase 2

Frequently Asked Questions

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

To what degree has MRI + Fluciclovine PET-guided radiotherapy been proven to be innocuous for individuals?

"With a score of 2, the safety profile for MRI + Fluciclovine PET-guided radiotherapy is classified as relatively secure due to existing data from Phase 2 trials which has not yet produced evidence in support of its efficacy."

Answered by AI

Is this a pioneering attempt with respect to treatment?

"Presently, 3 ongoing clinical trials involving MRI + Fluciclovine PET-guided radiotherapy have been launched in 3 cities across 1 nation. The earliest trial was conducted by Blue Earth Diagnostics in 2018 and included 30 participants who completed Phase 2 drug approval. Since then, 8 additional studies have concluded their research."

Answered by AI

Have any prior trials incorporated Magnetic Resonance Imaging and Fluciclovine Positron Emission Tomography for radiation therapy?

"Presently, there are 3 trials underway assessing the efficacy of MRI + Fluciclovine PET-guided radiotherapy. However, none of these initiatives have reached phase three yet. As most studies take place in Salt Lake City, Utah; participants can nevertheless find research sites at 3 additional locations."

Answered by AI

How many participants are involved in the trial?

"Affirmative. Evidence on clinicaltrials.gov supports the fact that this medical experiment, which was initially posted on June 7th 2021, still requires participants to join. 100 patients will be admitted at a single site."

Answered by AI

Are there any vacancies available for prospective subjects of this experiment?

"Affirmative, the particulars posted on clinicaltrials.gov indicate that this research is actively searching for willing subjects. It was initially published on June 7th 2021 and most recently amended on January 11th 2023. The trial aims to involve 100 participants from one location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma
2021. "Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840069.
~26 spots leftby Apr 2025
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