Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.

NCT03423082 | Terminated Phase 4 Results FDA Drug FDA Device

• 1 other identifier: PRO17120310
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Lesion Metabolic Avidity

  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

  Two weeks

Secondary Outcomes (3)

• Optimal Imaging Window

  One hour

• Fluciclovine PET Time-activity Curve Correlation With Histopathologic Tumor Grading

  One hour

• Textural Tumor Heterogeneity

  Two weeks

Study Arms (1)

18F fluciclovine PET scan

EXPERIMENTAL

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; Device: 18F fluciclovine PET

Interventions

18F fluciclovine DRUG

Each subject will receive one IV dose of 18F fluciclovine for PET scanning

Also known as: Axumin

18F fluciclovine PET scan

18F fluciclovine PET DEVICE

Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner

18F fluciclovine PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nghi Nguyen: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

UPMC Presbyterian - MR Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Nghi C. Nguyen, MD, PhD
• Organization: University of Pittsburgh

nguyennc@upmc.edu

412-647-0104

Study Officials

• Nghi C Nguyen, MD, PhD

  Assistant Professor of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 6, 2018
• Study Start: December 11, 2018
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)