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PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI

NCT05172310 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2021-12-29

No results posted yet for this study

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).

Conditions

  • Pancreatic Neoplasms
  • Stomach Neoplasms
  • Bile Duct Neoplasms
  • Epithelial Ovarian Cancer

Interventions

DRUG

68Ga-FAPI-46

* \[68Ga\] Ga-FAPI-46 Solution for Injection is manufactured at the Karolinska University Hospital Radiopharmacy facilities, for imaging studies with Positron Emission Tomography (PET). * It is a radiolabelled Fibroblast Activation Protein Inhibitor (FAPI) used for PET of a number of different cancer entities. * Depending on the labelling yield 50 - 370 megabecquerel (MBq) of \[68Ga\] Ga-FAPI-46 Solution for Injection will be administered intravenously 60 minutes prior to whole-body PET image acquisition.

DEVICE

PET/CT

* Combined PET and computed tomography (CT) imaging with 68Ga-FAPI-46 will be performed using the same protocol on a "Biograph 6" PET/CT scanner (Siemens, Erlangen, Germany) and "General Electrics" (GE) Discovery 710, Milwaukee, Wisconsin, USA at the Department of Nuclear Medicine, Karolinska Huddinge within 2 weeks before surgery. * PET/CT imaging will be performed in dynamic mode at one bed position centered over the primary tumor for 45 minutes. * At 60 minutes post injection, a whole-body PET will be acquired.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Rimma Axelsson, Professor · Medical Radiation Physics and Nuclear Medicine, Karolinska University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2024-06-30
Completion
2029-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172310 on ClinicalTrials.gov