NIPH Clinical Trials Search

FAPET study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	gynecologic malignancy, gastric cancer, head and neck cancer, pancreas cancer and breast cancer
Date of first enrollment	07/04/2026
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	Perform [68Ga]Ga- HKG301 PET and [18F]FDG PET in patients with malignant solid tumors at the time of staging, re-staging, and Neoadjuvant therapy.

Outcome(s)

Primary Outcome	Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of [68Ga]Ga-HKG301 PET in staging and restaging of malignant solid tumors.
Secondary Outcome	1)Exploring the utility of [68Ga]Ga-HKG301 PET for patients treated with Neoadjuvant therapy 2)[68Ga]Ga-HKG301 Biomarker search for PET-positive malignant solid tumors 3)Association of [68Ga]Ga-HKG301 accumulation with ultrasound elastography findings in breast cancer

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Patients diagnosed with malignant solid tumors, including gynecologic malignancy, gastric cancer, head and neck cancer, pancreas cancer and breast cancer, on histopathological examination, those strongly suspected of having the malignant solid tumors clinically or radiologically, or those with a history of the malignant solid tumors and suspicious of their metastasis or recurrence. 2)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 or 2. 3)Women or men who are at least 18 years of age at the time consent is obtained. 4)Written consent for participation in the study has been obtained from the patient themselves.
Exclude criteria	1)Previous history of allergy to [68Ga]Ga-FAP-targeted PET tracers. 2)Pregnant or breast-feeding 3)Patients in extremely poor general condition or with significant communication difficulties who are expected to have difficulty completing the examination. 4)Others who are deemed inappropriate as research subjects by the principal investigator, the subinvestigator, or the co-investigators.