Back to results18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Primary Purpose
Brain Metastases, Brain Metastases, Adult, Brain Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F fluciclovine
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases focused on measuring stereotactic radiosurgery, 18F-flucicloivine, PET imaging
Eligibility Criteria
Inclusion Criteria: Diagnosis of cancer with radiographic finding of brain metastasis Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension Planned treatment with SRS as per the treating physician team Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET Exclusion Criteria: Prior anaphylactic reaction to 18F-fluciclovine Radiographic evidence of leptomeningeal disease Prior whole-brain radiation therapy Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker) Pregnant or positive serum pregnancy test within 14 days of registration Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 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 and/or preclude informed consent* A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
Sites / Locations
- Miami Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-Fluciclovine PET Imaging
Arm Description
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
Outcomes
Primary Outcome Measures
Change in Standardized Uptake Value (SUV)-peak
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Change in SUVmean
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Change in SUVmax
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Secondary Outcome Measures
Tumor Control
Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.
Full Information
NCT ID
NCT06048094
First Posted
September 15, 2023
Last Updated
September 15, 2023
Sponsor
Baptist Health South Florida
Collaborators
Blue Earth Diagnostics
1. Study Identification
Unique Protocol Identification Number
NCT06048094
Brief Title
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Acronym
FACILITATE
Official Title
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
Blue Earth Diagnostics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Brain Metastases, Adult, Brain Cancer
Keywords
stereotactic radiosurgery, 18F-flucicloivine, PET imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-Fluciclovine PET Imaging
Arm Type
Experimental
Arm Description
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
Intervention Type
Drug
Intervention Name(s)
18F fluciclovine
Other Intervention Name(s)
Axumin, 18F-FACBC, (1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid
Intervention Description
Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection 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 Outcome Measure Information:
Title
Change in Standardized Uptake Value (SUV)-peak
Description
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time Frame
8 weeks
Title
Change in SUVmean
Description
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time Frame
8 weeks
Title
Change in SUVmax
Description
Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Tumor Control
Description
Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cancer with radiographic finding of brain metastasis
Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
Planned treatment with SRS as per the treating physician team
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
Exclusion Criteria:
Prior anaphylactic reaction to 18F-fluciclovine
Radiographic evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
Pregnant or positive serum pregnancy test within 14 days of registration
Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 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 and/or preclude informed consent*
A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupesh Kotecha, M.D.
Phone
(786) 596-2000
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Carolina Avendaño
Phone
(786) 527-8863
Email
MariaAve@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, M.D.
Organizational Affiliation
Miami Cancer Institute at Baptist Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, M.D.
Phone
786-596-2000
Email
RupeshK@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Maria Carolina Avendaño
Phone
(786) 527-8863
Email
MariaAve@baptisthealth.net
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28277832
Citation
Galldiks N, Langen KJ. Amino acid PET in neuro-oncology: applications in the clinic. Expert Rev Anticancer Ther. 2017 May;17(5):395-397. doi: 10.1080/14737140.2017.1302799. Epub 2017 Mar 11. No abstract available.
Results Reference
background
PubMed Identifier
26022202
Citation
Doi Y, Kanagawa M, Maya Y, Tanaka A, Oka S, Nakata N, Toyama M, Matsumoto H, Shirakami Y. Evaluation of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid accumulation in low-grade glioma in chemically induced rat models: PET and autoradiography compared with morphological images and histopathological findings. Nucl Med Biol. 2015 Aug;42(8):664-72. doi: 10.1016/j.nucmedbio.2015.04.008. Epub 2015 May 7.
Results Reference
background
PubMed Identifier
33284388
Citation
Parent EE, Patel D, Nye JA, Li Z, Olson JJ, Schuster DM, Goodman MM. [18F]-Fluciclovine PET discrimination of recurrent intracranial metastatic disease from radiation necrosis. EJNMMI Res. 2020 Dec 7;10(1):148. doi: 10.1186/s13550-020-00739-6.
Results Reference
background
PubMed Identifier
34406623
Citation
Wakabayashi T, Hirose Y, Miyake K, Arakawa Y, Kagawa N, Nariai T, Narita Y, Nishikawa R, Tsuyuguchi N, Fukami T, Sasaki H, Sasayama T, Kondo A, Iuchi T, Matsuda H, Kubota K, Minamimoto R, Terauchi T, Nakazato Y, Kubomura K, Wada M. Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Ann Nucl Med. 2021 Dec;35(12):1279-1292. doi: 10.1007/s12149-021-01670-z. Epub 2021 Aug 18.
Results Reference
background
PubMed Identifier
17189070
Citation
Gondi V, Bradley K, Mehta M, Howard A, Khuntia D, Ritter M, Tome W. Impact of hybrid fluorodeoxyglucose positron-emission tomography/computed tomography on radiotherapy planning in esophageal and non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):187-95. doi: 10.1016/j.ijrobp.2006.09.033.
Results Reference
background
Links:
URL
http://cancer.baptisthealth.net/
Description
Miami Cancer Institute
Learn more about this trial
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
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