NCT04689048

Brief Summary

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
19mo left

Started Apr 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Apr 2022Dec 2027

First Submitted

Initial submission to the registry

December 11, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

December 11, 2020

Last Update Submit

April 20, 2026

Conditions

Brain Metastases, AdultBrain MetastasesBrain Cancer

Keywords

brainbrain metastasesbrain metastases, adultbrain cancerStereotactic Radiosurgery

Outcome Measures

Primary Outcomes (3)

  • Change in sensitivity for PET/CT

    Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS.

    through study completion, an average of 1 year

  • Change in sensitivity for MRI

    To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

    through study completion, an average of 1 year

  • Change in the standardized uptake value (SUV) parameters

    To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Compare change of SUV metrics of 18F-fluciclovine PET

    baseline

  • Compare change of SUV metrics of contrast-enhanced MRI

    baseline

Study Arms (1)

PET/CT, MRI

OTHER

In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.

Drug: 18F fluciclovine

Interventions

18F fluciclovineDRUG

Patients will receive a standard 5 millicuries dose 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.

Also known as: Axumin
PET/CT, MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age ≥18 years
  • Performance status, Eastern Cooperative Oncology Group 0-2
  • Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
  • Plan for SSRS per the treating team
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
  • For females of reproductive potential: use of highly effective 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 positron emission tomography/computerized tomography

You may not qualify if:

  • 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)
  • Females pregnant at the expected time of 18F-fluciclovine administration
  • Females who are 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
  • Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Related Publications (1)

  • Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.

    PMID: 34081125DERIVED

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rupesh R Kotecha, MD

    Miami Cancer Institute (MCI) at Baptist Health, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupesh C Kotecha, MD

CONTACT

17865962000rupeshk@baptisthealth.net

Kristy Reyes

CONTACT

786-524-7311Kristina.Reyes@baptisthealth.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (\>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 30, 2020

Study Start

April 4, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)