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

NCT05172310 | Recruiting Phase 1 DMC

• 2 other identifiers: H035-FAPI2020-002568-30
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

68-Ga FAPI; PET/CT; Pancreatic Neoplasms; Stomach Neoplasms; Bile Duct Neoplasms; Fibroblast activating protein inhibitor; FAPI; Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of FAPI-PET/CT in primary tumors

  To validate the proportion of false-positive and false-negative FAPI-PET/CT findings in primary pancreas, biliary and gastric tumors as well as in primary and recurrent EOC with postsurgical or true cut biopsy histopathological confirmation of diagnosis (PAD) as a reference standard

  up to 18 months

Secondary Outcomes (6)

• Diagnostic accuracy of FAPI-PET/CT in metastases

  up to 18 months

• Immunohistochemistry

  up to 18 months

• FAPI-PET/CT and stroma markers as prognostic factors for Disease Free Survival (DFS)

  up to 5 years

• FAPI-PET/CT and stroma markers as prognostic factors for Overall Survival (OS)

  up to 5 years

• Correlation between FAPI-PET/CT imaging results and those of conventional radiology

  up to 18 months

Study Arms (2)

Cancer patients

EXPERIMENTAL

* Adults with suspected cancer of either pancreas, bile ducts or stomach * Adults with primary and recurrent epithelial ovarian cancer (EOC)

Drug: 68Ga-FAPI-46; Device: PET/CT

Non cancer patients

ACTIVE COMPARATOR

Non cancer patients operated for non-malignant diseases in pancreas during the same period of time will be investigated with the same procedure.

Drug: 68Ga-FAPI-46; Device: PET/CT

Interventions

68Ga-FAPI-46 DRUG

* \[68Ga\] 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.

Cancer patients; Non cancer patients

PET/CT DEVICE

* 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.

Cancer patients; Non cancer patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known metastatic disease

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital Huddinge

Stockholm, 14186, Sweden

RECRUITING

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MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Bile Duct Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

FAPI-46; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Rimma Axelsson, Professor

  Medical Radiation Physics and Nuclear Medicine, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rimma Axelsson, Professor

CONTACT

+46 708 227 622; rimma.axelsson@ki.se

Siri af Burén, MD

CONTACT

+46-739099570; siri.afburen@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Investigators select subjects that are scheduled for * surgical removal of either a malignant lesion in the pancreas, bile ducts, or stomach (first arm) * surgical removal of primary stage epithelial cancer of the ovary (EOC), interval debulking surgery (IDS) of EOC or surgical removal/tissue biopsy of recurrent EOC (first arm) * surgical removal of a benign lesion in the pancreas (second arm) All patients will undergo a PET/CT with the interventional drug/radiotracer 68Ga-FAPI-46 before surgery.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 29, 2021
• Study Start: June 2, 2021
• Primary Completion: June 30, 2024
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)