NCT05172310 PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
| NCT ID | NCT05172310 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Karolinska University Hospital |
| Condition | Pancreatic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2021-06-02 |
| Primary Completion | 2024-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 410 participants in total. It began in 2021-06-02 with a primary completion date of 2024-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cancers of the pancreas, bile ducts, stomach and ovaries are dismal diseases with most patients being diagnosed in advanced stages leading to a bad prognosis. These cancers can be difficult to diagnose and sometimes impossible to differentiate from underlying benign conditions. Establishing the correct diagnosis of primary cancer lesions and possible spread to other organs in time is pivotal for choosing the right therapy. Routinely applied staging procedures are however not always reliable. The main aim in this study is to evaluate the diagnostic accuracy of PET/CT with a novel radiotracer, FAPI, in the primary diagnosis of cancers in the pancreas, stomach and bile ducts as well as in patients with primary and recurrent epithelial ovarian cancer (EOC).
Eligibility Criteria
Inclusion Criteria: * Consecutive patients scheduled for surgical removal of either a pancreatic, biliary or gastric lesion. \- Consecutive patients scheduled for primary surgical removal of early stage epithelial ovarian cancer (EOC), interval debulking surgery of EOC or surgical removal or tissue biopsy of recurrent EOC * Signed informed consent. Common Exclusion Criteria for all study populations: * Age ≤18 year * Pregnancy and lactation * Significantly reduced renal function * Allergy to iodinated contrast media * Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment. Additional Exclusion Criteria for study populations with either pancreatic-, gastric or bile duct cancer: • Known metastatic disease
Frequently Asked Questions
Who can join the NCT05172310 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05172310 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05172310 currently recruiting?
Yes, NCT05172310 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska University Hospital to inquire about joining.
Where is the NCT05172310 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05172310 clinical trial?
NCT05172310 is sponsored by Karolinska University Hospital. The trial plans to enroll 410 participants.