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NCT Number: NCT05554302

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

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Key information

Conditions

Brain Metastases Brain Cancer 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

Phase 2

Primary location

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176, United States

Location status: Recruiting

Location contact

Rupesh Kotecha, MD

CONTACT

[email protected]

786-527-7642

Rupesh Kotecha, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
  • Radiographic diagnosis of brain metastasis
  • Patient planned for surgical intervention for at least 1 metastasis
  • Patient planned for postoperative SRS

Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are:

  • Male condom plus spermicide
  • Cap plus spermicide
  • Diaphragm plus spermicide
  • Copper T
  • Progesterone T
  • Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
  • Implants
  • Hormone shot or injection
  • Combined pill
  • Mini-pill
  • Patch

Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:

  • Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
  • Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
  • Radiation-induced oophorectomy with last menses > 1 year ago
  • Chemotherapy-induced menopause with >1 year interval since last menses
  • Surgical sterilization (bilateral oophorectomy or hysterectomy).

Exclusion criteria

  • Prior anaphylactic reaction to 18F-Fluciclovine
  • Evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  • Pregnant at the expected time of 18F-fluciclovine administration
  • Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.

Treatment and study plan

18F-fluciclovine

Drug

Patients will receive 5-mCi dose (+/- 20%) of 18F-Fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-Fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-Fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Primary outcomes

  1. Change in conformality index of tumor target volume delineation

    Time frame: 3 weeks, 6 and 12 months

    The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.

  2. Change in PET scan standardized uptake value (SUV) parameters

    Time frame: 3 weeks, 6 and 12 months

    The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.

Secondary outcomes

  1. Time to local failure

    Time frame: 1 year

    Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoinette Pimentel

CONTACT

[email protected]

17865962000

Rupesh R Kotecha, M.D.

CONTACT

[email protected]

17865962000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Acronym: CONCORDANT

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Sep 26, 2022
Registry last updated
Dec 1, 2025

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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