NCT03423082 is a Phase 4 clinical trial of 18F fluciclovine in Cervical Cancer, sponsored by Nghi Nguyen.

Who is sponsoring NCT03423082?

NCT03423082 is sponsored by Nghi Nguyen.

What drugs are being tested in NCT03423082?

Interventions in NCT03423082: 18F fluciclovine, 18F fluciclovine PET.

What condition does NCT03423082 study?

NCT03423082 studies Cervical Cancer, Uterine Cancer.

Is NCT03423082 still recruiting?

NCT03423082 is currently terminated. Last updated 28 October 2020.

Are results published for NCT03423082?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-28 · How we verify

NCT03423082

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Results posted Last updated 28 October 2020

What this trial tests

Phase 4 trial testing 18F fluciclovine in Cervical Cancer in 1 participant. Terminated before completion.

Timeline

11 December 2018

Primary endpoint
18 December 2019

18 December 2019

Quick facts

Lead sponsor	Nghi Nguyen
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1
Start date	11 December 2018
Primary completion	18 December 2019
Estimated completion	18 December 2019
Sites	1 location across United States

Drugs / interventions tested

18F fluciclovine — full drug profile →
18F fluciclovine PET

Conditions studied

Cervical Cancer — all drugs for Cervical Cancer →
Uterine Cancer — all drugs for Uterine Cancer →

Sponsor

Nghi Nguyen — full company profile →

Who can join

18 and older, female only, with Cervical Cancer or Uterine Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lesion Metabolic Avidity Primary · Two weeks

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

SUV of standard-of-care FDG

Group	Value	95% CI
18F Fluciclovine PET Scan	21.5

SUV of research Fluciclovine

Group	Value	95% CI
18F Fluciclovine PET Scan	6.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of 18F fluciclovine

Trials testing the same drug.

NCT04410133 — Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases · Phase 3 · completed
NCT04410367 — Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSU · Phase 2 · completed

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03423082 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nghi Nguyen
Last refreshed: 28 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03423082.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing