Metastatic Intracranial Malignant NeoplasmNCT04462419
18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
An observational study of Metastatic Intracranial Malignant Neoplasm and Recurrent Intracranial Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Intracranial Malignant Neoplasm, Recurrent Intracranial Neoplasm
- What is being tested?
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography and Fluciclovine F18
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to 13 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.
Who may be able to join
- Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion')
Who cannot join
- Contraindication to contrast enhanced MRI
- Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm)
- Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging
- Inability or refusal to consent
- Allergy or anaphylaxis to any of the reagents used in this study
- Inability or unwillingness to return for required visits and follow-up exams
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: 18F-Fluciclovine PET Discrimination of Radiation Injury to the Brain
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (MRI) findings suggesting recurrent disease, using histopathology as proof of disease.
SECONDARY OBJECTIVES:
- To determine static fluciclovine PET standardized uptake value (SUV)peak, SUVmean values and metabolic tumor volumes (MTV) which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using serial MRI as a surrogate marker of disease.
II. To determine early dynamic fluciclovine PET time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using histopathology or serial MRI as a marker of disease.
III. To correlate the determined static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival.
IV. In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology.
OUTLINE:
Patients receive fluciclovine intravenously (IV) and undergo brain dynamic PET/MRI imaging over 50 minutes.
After completion of study, patients are followed up every 3 months for up to 1 year.
- Being tested
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography, Fluciclovine F18
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission TomographyRadiation
Also called DCE-MRI with PET, DCE-MRI/PET
Undergo PET-MRI imaging
Fluciclovine F18Other
Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (18F-fluciclovine, PET/MRI imaging) | Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes. Receives: Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography; Other: Fluciclovine F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-to-background ratios (TBR)max and TBRmean thresholds
Will be estimated to delineate tumor progression from radionecrosis for use in future studies. The optimal TBRmax and TBRmean thresholds will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%.
Measured: Up to 4 weeks post study registration
Secondary outcomes (4)
Static values for fluciclovine PET standardized uptake value (SUV)peak that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Determined using serial MRI as a surrogate marker of disease.The optimal SUVpeak, SUVmean and metabolic tumor volumes (MTV) values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%.
Measured: Up to 4 weeks post study registration
Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Determined using serial MRI as a surrogate marker of disease. The optimal SUVmean values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%.
Measured: Up to 4 weeks post study registration
Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Determined using serial MRI as a surrogate marker of disease. The optimal MTV values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%.
Measured: Up to 4 weeks post study registration
Incidence of adverse events
Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Measured: Every 3 months up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start18 Aug 2020
- Primary completion13 Dec 2023
- Study completion13 Nov 2024
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Intracranial Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Daniel M. Trifiletti, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462419
- Sponsor's protocol ID
- MC1975
- Other IDs
- NCI-2020-04564, MC1975, 19-004459
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2020
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34081125
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluciclovine PET Discrimination of Radiation Injury to the Brain
- ClinicalTrials.gov ID
- NCT04462419
- Acronym / sponsor ID
- MC1975
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.
Detailed description
PRIMARY OBJECTIVE:
- To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (MRI) findings suggesting recurrent disease, using histopathology as proof of disease.
SECONDARY OBJECTIVES:
- To determine static fluciclovine PET standardized uptake value (SUV)peak, SUVmean values and metabolic tumor volumes (MTV) which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using serial MRI as a surrogate marker of disease.
II. To determine early dynamic fluciclovine PET time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using histopathology or serial MRI as a marker of disease.
III. To correlate the determined static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival.
IV. In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology.
OUTLINE:
Patients receive fluciclovine intravenously (IV) and undergo brain dynamic PET/MRI imaging over 50 minutes.
After completion of study, patients are followed up every 3 months for up to 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (18F-fluciclovine, PET/MRI imaging) | – | Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography, Other: Fluciclovine F18Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.
Key inclusion criteria (1 listed)
- Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion')
Key exclusion criteria (6 listed)
- Contraindication to contrast enhanced MRI
- Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm)
- Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging
- Inability or refusal to consent
- Allergy or anaphylaxis to any of the reagents used in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission TomographyAlso: DCE-MRI with PET, DCE-MRI/PETUndergo PET-MRI imaging | Radiation | Diagnostic (18F-fluciclovine, PET/MRI imaging) |
| Fluciclovine F18Also: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBCGiven IV | Other | Diagnostic (18F-fluciclovine, PET/MRI imaging) |
Primary outcome
Tumor-to-background ratios (TBR)max and TBRmean thresholds
Time frame: Up to 4 weeks post study registration
Will be estimated to delineate tumor progression from radionecrosis for use in future studies. The optimal TBRmax and TBRmean thresholds will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%.
4 secondary outcomes
Static values for fluciclovine PET standardized uptake value (SUV)peak that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Time frame: Up to 4 weeks post study registration
Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Time frame: Up to 4 weeks post study registration
Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
Time frame: Up to 4 weeks post study registration
Incidence of adverse events
Time frame: Every 3 months up to 1 year
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Derived from this study: PubMed 34081125Kotecha 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M. Trifiletti, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Intracranial Malignant Neoplasm and Recurrent Intracranial Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-to-background ratios (TBR)max and TBRmean thresholds (time frame: Up to 4 weeks post study registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.