Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.
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|ClinicalTrials.gov Identifier: NCT03423082|
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : December 14, 2018
18F Fluciclovine is a recently FDA- approved radiopharmaceutical for prostate cancer biochemical recurrence, which is only minimally eliminated by the kidneys and therefore the image interpretation is not affected by nonspecific urine activity in the ureters and bladder, which is advantageous for pelvic imaging. Recent literature suggests that Fluciclovine PET has diagnostic potential for a variety of solid tumors, thus, allowing new opportunities for noninvasive probing of glutamine metabolism and clinical use in patient management. Current literature indicates that amino acid transporters including that of glutamine are upregulated in endometrial and cervical cancer so that Fluciclovine PET may have clinical potentials. The hypothesis is that Fluciclovine PET provides better imaging properties and greater diagnostic confidence and accuracy than FDG PET does in pelvic malignancies.
Given the lack of current clinical data, a pilot study providing a direct comparison of Fluciclovine PET with FDG PET is warranted. The investigators seek to conduct a pilot study with 10 subjects to evaluate the clinical utility of Fluciclovine PET for staging of cervical cancer and endometrial cancer. This research will compare the diagnostic performance of the research Fluciclovine PET/MRI with the standard-of-care FDG PET/CT as an exploratory endpoint.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Uterine Cancer||Drug: 18F fluciclovine Device: 18F fluciclovine PET||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer Compared With 18F FDG PET|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: 18F fluciclovine PET scan
Subjects with recently biopsy-proven malignancy of the cervix or uterus undergo an 18F fluciclovine PET scan on a hybrid PET/MRI scanner after they have completed a standard-of-care F-18 FDG PET/CT study.
Drug: 18F fluciclovine
Each subject will receive one IV dose of 18F fluciclovine for PET scanning
Device: 18F fluciclovine PET
Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
- Lesion metabolic avidity [ Time Frame: One year ]Metabolic parameter of maximum standard-uptake-value (SUV) will be compared between research Fluciclovine PET and standard-of-care FDG PET to determine lesion metabolic avidity
- Optimal imaging window [ Time Frame: One year ]The optimal time window for tumor detection (primary, nodal metastasis) relative to physiologic and benign structures will be determined based on time-activity curves of the Fluciclovine PET scan.
- Fluciclovine PET time-activity curve correlation with histopathologic tumor grading [ Time Frame: One year ]The Fluciclovine time-activity curve of the primary tumor (time to peak, uptake intensity, and slope of washout) will be correlated with histopathologic tumor grading.
- Textural tumor heterogeneity [ Time Frame: One year ]Parameters of textural tumor heterogeneity will be compared between Fluciclovine PET and FDG PET, using the open-access LIFEx software. The software allows for an automatic evaluation of more than 50 parameters for textural analyses and shows the result of the best parameters for tumor heterogeneity; however, no specific marker or measure of heterogeneity is be predefined in this process.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423082
|Contact: Suzanne Burdinfirstname.lastname@example.org|
|Contact: Rose Jaroszemail@example.com|
|United States, Pennsylvania|
|UPMC Presbyterian - MR Research Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Suzanne Burdin firstname.lastname@example.org|
|Contact: Rose Jarosz email@example.com|
|Principal Investigator:||Nghi C Nguyen, MD, PhD||Assistant Professor of Radiology|