Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if \[68Ga\]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that \[68Ga\]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups. The main questions the trial aims to answer are: * Is \[68Ga\]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities? * Can \[68Ga\]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min? Researchers will examine three different patient groups: Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy). Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment. Participants will undergo: * One \[68Ga\]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2). * Participants in group B2 will also undergo a second \[68Ga\]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy. * All participants will fill out one questionnaire. * Researchers will follow the patients after the scans for 1 year.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, over 18 years old

• Patients with suspected pancreatic cancer based on morphological findings on standard imaging

• CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases

• Subjects must have been considered suitable for curative surgery at the time of the referral

• Subjects must be able to read and understand the patient information in Danish to give informed consent

• Male or female over 18 years old

• Histological verified carcinoma from the lower esophagus, GEJ, or stomach

• Subjects must be considered operable and resectable at the time of referral for MDT

• Subjects must be able to read and understand the patient information in Danish to give informed consent

• Male or female over 18 years old

• Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach

• Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.

• Subjects must be able to read and understand the patient information in Danish to give informed consent

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Marie M K Stolberg, MD
marie.manon.krebs.krarup@regionh.dk
+4535454416
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2027-01
Participants
Target number of participants: 90
Treatments
Experimental: Cancer patients
Related Therapeutic Areas
Sponsors
Collaborators: Danish Cancer Society, Herlev Hospital
Leads: Barbara Malene Fischer

This content was sourced from clinicaltrials.gov