[⁶⁸Ga]Ga-HKG301(FAP-2286) PET/CT in pancreatic and breast malignancies

Other illness

• Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the clinical trial protocol and follow-up schedule.
• Known hypersensitivity to radiotracers, or compounds of HKG301.

Lab values

• Significantly impaired renal function (creatinine clearance < 60 mL/min according to CKD-EPI).

Other

• Pregnancy or breastfeeding.
• Inability to undergo PET/CT scanning (e.g., severe claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan).

• Adults (≥18 years) with suspicion of and/or histopathology-proven PDAC with primarily resectable tumor and serum CA19-9 levels > 500 U/mL and/or inconclusive findings on conventional imaging.
• Female adults (≥18 years) with histopathology-proven invasive lobular breast cancer patients with unfavorable receptor status (any stage with HER2-positive or ER < 10%) or with clinical stage II (≥ cT2) or stage III disease.
• Patients who have undergone or are scheduled for standard initial staging with ceCT, MRI, and [¹⁸F]FDG PET/CT.
• Patients who gave free written consent to participate in the clinical trial through the Informed Consent Form.
• Patients willing to comply with all clinical trial procedures and show availability for the duration of the clinical trial.
• Patients with an ECOG performance status ≤ 2.