RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.

Official 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

Quick Facts

Study Start:2024-11-07

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06015295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Yang Lu, MD

CONTACT

(713) 792-5768

ylu10@mdanderson.org

Principal Investigator

Yang Lu, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Yang Lu, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-07

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-11-07

Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

Brain Metastases