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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
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Nghi Nguyen, University of Pittsburgh

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 18 years and older
  • Biopsy-proved cervical cancer or endometrial cancer within three months of study enrollment
  • Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment

Exclusion Criteria:

  • Female < 18 years old
  • No history of cervical cancer or endometrial cancer
  • Primary biopsy > 3 months of study enrollment
  • Systemic therapy or radiation therapy initiated
  • SOC FDG PET/CT exam performed > 30 days of study enrollment
  • Therapeutic procedures (chemotherapy, radiation therapy) have been initiated
  • Pregnancy or lactation
  • Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner
  • Individual is not willing to give informed consent

Information from the National Library of Medicine

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


Contacts
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Contact: Suzanne Burdin 412-647-7385 burdins@upmc.edu
Contact: Rose Jarosz 412-647-4970 jaroszr@upmc.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian - MR Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Suzanne Burdin       burdins@upmc.edu   
Contact: Rose Jarosz       jaroszr@upmc.edu   
Sponsors and Collaborators
Nghi Nguyen
Blue Earth Diagnostics
Investigators
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Principal Investigator: Nghi C Nguyen, MD, PhD Assistant Professor of Radiology

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Responsible Party: Nghi Nguyen, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03423082     History of Changes
Other Study ID Numbers: PRO17120310
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available for this pilot study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female