gynecologic malignancy, gastric cancer, head and neck cancer, pancreas cancer and breast cancer malignant solid tumors
Conditions
Interventions
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.
Sponsors
Nakamoto Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKanae Miyake
Kyoto University Graduate School of Medicine
Outcome results
None listed