NIPH Clinical Trials Search

Detection of mandibular gingival cancer, using fluciclovine PET/CT

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Mandibular gingival carcinoma (including central mandibular carcinoma)
Date of first enrollment	29/09/2025
Target sample size	5
Countries of recruitment	Not applicable,Japan
Study type	Interventional
Intervention(s)	Administration of fluciclovine (^18F-FACBC) PET/CT to evaluate tracer uptake in mandibular gingival carcinoma (including central mandibular carcinoma). The uptake patterns will be compared with those of standard FDG-PET/CT and correlated with histopathological findings of resected specimens.

Outcome(s)

Primary Outcome	Fluciclovine PET uptake in mandibular gingival carcinoma (including central mandibular carcinoma)
Secondary Outcome	If uptake in the tumour is confirmed, the following will be evaluated: - Comparison of tumour uptake extent with FDG PET images - Numerical comparison using semi-quantitative parameters (SUV parameters) - Comparison between the resected pathological specimen volume and uptake on fluciclovine PET/CT or FDG PET/CT

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	< 75age old
Gender	Both
Include criteria	Inclusion Criteria Patients who meet all of the following criteria will be eligible for this study: 1. Patients with mandibular gingival carcinoma (in cluding central mandibular carcinoma) who requir e surgical treatment based on the Clinical Practice Guidelines for Oral Cancer. 2. Patients aged 20 years or older and younger th an 75 years at the time of obtaining informed cons ent. 3. Patients with a performance status of 0-1. 4. Patients from whom written informed consent f or participation in this study can be obtained.
Exclude criteria	Exclusion Criteria Patients who meet any of the following criteria will be excluded from the study: 1. Patients who are pregnant, breastfeeding, or possibly pregnant. 2. Patients judged to be inappropriate for particip ation by the principal investigator or sub-investiga tors. 3. Patients whose scheduled surgery date is less t han 7 days after providing informed consent for this study. 4. Patients with hypersensitivity to the components of the investigational drug.