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NCT Number: NCT03930173

18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis

The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive.

18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.

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Key information

Conditions

Secondary Malignant Neoplasm of Brain and Cerebral Meninges Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

The primary objective of this study is to estimate the accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression. Accuracy will be assessed via receiver operating characteristic curve analysis, as well as by calculating sensitivity and specificity.

Secondary objectives of this study are to assess which factors may influence accuracy of 18Ffluciclovine PET in distinguishing radiation necrosis from tumor progression and to compare the accuracy of each of the qualitative and quantitative metrics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have a confirmed diagnosis of brain metastases.
  • Subjects must have received prior intracranial SRS at least once for brain metastases. Prior WBRT is allowed.
  • Subjects must have had a clinical tumor protocol MRI of the brain including a DSC-MR perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. "Equivocal" will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist.
  • Physician assessed life expectancy of ≥ 6 months.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required.

Exclusion criteria

  • Subjects who have experienced a prior anaphylaxis reaction to 18Ffluciclovine are not eligible.
  • Females pregnant at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. Women who could be pregnant require a negative pregnancy test to be eligible.
  • Women who are breast feeding at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation.
  • Subjects contraindicated for MRI.
  • Subjects unable or unwilling to comply with study requirements are not eligible.
  • Major medical illness or psychiatric impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent.
  • Brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma.

Treatment and study plan

18F-fluciclovine

Drug

A single dose of 18F-fluciclovine will be administered intravenously for PET/CT imaging. The standard 10 mCi dose will be used for this study.

PET/CT of the brain

Device

Each subject will undergo 18F-fluciclovine PET/CT of the brain which will be performed ≤ 30 days from equivocal MRI brain

Primary outcomes

  1. Accuracy of 18F-fluciclovine PET as measured by area under the ROC curve (AUC)

    Time frame: Up to 1 year from start of study

    The accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression will be reported. Accuracy will be assessed via receiver operating characteristic curve analysis.

Secondary outcomes

  1. 18F-fluciclovine uptake in lesions, compared to normal brain tissue.

    Time frame: Up to 1 year from start of study

    18F-fluciclovine uptake in lesions will be reported in comparison to normal brain tissue.

  2. Sensitivity and specificity of 18F-fluciclovine PET

    Time frame: Up to 1 year from start of study

    Sensitivity and specificity of 18F-fluciclovine PET diagnostic procedure

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

A Prospective Pilot to Evaluate the Diagnostic Assessment of 18F-Fluciclovine Positron Emission Tomography to Distinguish Tumor Progression From Radiation Necrosis Following Stereotactic Radiosurgery for Brain Metastases

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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