Gastroesophageal Cancer (GC), Pancreatic Cancer, Adult
Conditions
Keywords
PET/CT, FAPI, pancreatic cancer, gastroesophageal cancer, signet ring cell carcinoma
Brief 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.
Interventions
DRUG[68Ga]Ga-FAPI-46
PET/CT scan with the tracer \[68Ga\]Ga-FAPI-46
Sponsors
Barbara Malene Fischer
Danish Cancer Society
Herlev Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for group A 1. Male or female, over 18 years old 2. Patients with suspected pancreatic cancer based on morphological findings on standard imaging 3. CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases 4. Subjects must have been considered suitable for curative surgery at the time of the referral 5. Subjects must be able to read and understand the patient information in Danish to give informed consent Inclusion criteria for group B1 1. Male or female over 18 years old 2. Histological verified carcinoma from the lower esophagus, GEJ, or stomach 3. Subjects must be considered operable and resectable at the time of referral for MDT 4. Subjects must be able to read and understand the patient information in Danish to give informed consent Inclusion criteria for group B2 1. Male or female over 18 years old 2. Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach 3. Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment. 4. Subjects must be able to read and understand the patient information in Danish to give informed consent
Exclusion criteria
1. Pregnancy or lactation 2. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 3. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI-46
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT | From the time of scan to the end of follow up at 1 year | Sensitivity of lesions suspicious of malignancy of \[68Ga\]Ga-FAPI-46 Total Body PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities (\[18F\]FDG PET/CT, CT, MRI). Sensitivity will be measured as the proportion of true positive malignant findings on \[68Ga\]Ga-FAPI-46 Total Body PET/CT within 30 mins of injection of the tracer. This will be done, by comparing the lesions suspicious of malignancy found on \[68Ga\]Ga-FAPI-46 PET/CT, and standard imaging with the results from the curative surgery and/or a composed reference standard, which consist of all available imaging, 6 months follow up and blinded expert opinion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT | From the time of scan to the end of follow up at 1 year | Sensitivity of lesions suspicious of malignancy of \[68Ga\]Ga-FAPI-46 Total Body PET/CT after 60 min of injection of the tracer, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV). Sensitivity (the proportion of true positive findings), specificity (the proportion of true negative findings), PPV (the proportion of positive findings, which are true positives) and NPV (the proportion of negative findings which are true negatives will be measured by comparing the lesions suspicious of malignancy found on \[68Ga\]Ga-FAPI-46 PET/CT and standard imaging with the results from the curative surgery and/or a composed reference standard, which is composed of all available imaging, 6 months follow up and blinded expert opinion. |
| Estimated potential impact/change in patient management. | From the time of scan to the end of follow up at 1 year | — |
| Description of FAPI-uptake from lesions suspicious of malignancy. | From the time of scan to the end of follow up at 1 year | FAPI-uptake in lesions suspicious of malignancy will be described and quantified with standardized uptake values (SUV, e.g. SUVmax, SUVmean). SUV is a ratio of the concentration of the tracer in a region of interest on the scan and the concentration of tracer injected in the participant. |
Countries
Denmark
Contacts
CONTACTMarie M K Stolberg, MD
Outcome results
None listed