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Trial Title:
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
NCT ID:
NCT06015295
Condition:
Brain Metastases
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-Fluciclovine (Axumin)
Description:
Given by Injection
Arm group label:
18F-Fluciclovine (Axumin)
Intervention type:
Diagnostic Test
Intervention name:
Pet Scan
Description:
Scans
Arm group label:
18F-Fluciclovine (Axumin)
Summary:
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain
metastatic lesions in patients who are receiving immunotherapy.
Detailed description:
Primary Objective:
- To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting
true- versus pseudo-progression of brain metastatic lesions in patients on
immunotherapy.
Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold
standard truth divided by the total sample size.
Secondary Objectives
- To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus
pseudo-progression of brain metastatic lesions in patients on immunotherapy by
additional accuracy measures including sensitivity, specificity, negative predictive
value and positive predictive value.
- To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with
metastatic brain lesion(s).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years. Because no dosing or adverse event data are currently available on
the use of Axumin in pediatric patients, patients <18 years of age are excluded from
this study.
2. ECOG performance status ≤2 (Karnofsky ≥60%,).
3. Willingness to participate in the study and ability to provide written informed
consent.
4. Patients must have documented brain metastatic lesion(s) in the medical record.
5. On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is
allowed. Immunotherapy and other treatment regimens are determined by treating
physicians as per standard clinical practice.
6. Patients with at least one metastatic brain lesion showing suspected
pseudoprogression on SoC imaging modality (such as CT, or MRI, or FDG PET-CT, or
DOTATATE PET/CT, or PSMA PET/CT).
7. The suspected pseudoprogresson can be determined by imaging physician (such as
neuroradiologists and/or nuclear medicine physicians) and/or treating physicians
(usually are oncologists). Ideally, the target/index lesion should be measurable (at
discretion of investigator imaging physicians) and feasible for series follow up and
comparison at imaging physician's discretion.
8. Ability and willingness to undergo another follow up Fluciclovine PET/CT, usually
within 60 days of SoC follow up imaging modality.
9. Ability and willingness to undergo biopsy if needed per standard of care.
10. Estimated life expectancy of at least 3 months as determined by the investigator or
treating physician.
Exclusion Criteria:
1. Pregnant or breastfeeding during participation in the study are excluded because:
There is no information on the risk of adverse developmental outcomes in pregnant
women or animals with the use of Fluciclovine F18. All radiopharmaceuticals,
including Axumin, have the potential to cause fetal harm depending on the fetal
stage of development and the magnitude of the radiation dose; There is no
information on the presence of Fluciclovine F18 in human milk, the effect on the
breastfed infant, or the effect on milk production.
2. History of severe allergic reactions to Axumin PET radiopharmaceuticals. Mild to
moderate reactions that can be controlled by medications prior to the scheduled
PET/CT are acceptable.
3. Patients with psychiatric illness/social situations that would limit compliance with
study requirements.
4. Unable to lie flat during or tolerate PET-CT
5. Contraindications to Axumin Injection have not been established in humans. None are
known or have been observed in nonclinical or clinical studies performed to date.
6. Subjects with any medical condition or circumstance that the investigator believes
may compromise the safety or compliance of the subject to produce reliable data or
completing the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Yang Lu, MD
Phone:
713-792-5768
Email:
ylu10@mdanderson.org
Investigator:
Last name:
Yang Lu, MD
Email:
Principal Investigator
Start date:
February 28, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015295
http://www.mdanderson.org
