[68Ga]Ga-FAPI total body PET/CT for improving diagnostic sensitivity and preoperative staging in gastroesophageal cancer and pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2023-06-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The overall aim of the study is to evaluate the diagnostic sensitivity of the tracer [68Ga]Ga-FAPI-46 with total body (TB) positron emission tomography (PET)/computed tomography (CT) compared to standard imaging in patients with gastroesophageal cancer and pancreatic cancer.

Secondary objectives 1

1. Evaluate the potential benefits of [68Ga]Ga-FAPI-46 TB PET/CT in terms of logistic and patient comfort.

Conditions and MedDRA coding

Pancreatic cancer and gastroesophageal cancer (esophagus, gastroesophageal junction (GEJ) and gastric cancer)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Inclusion criteria for group A 1)Male or female, =/>18 years old 2)Patients with suspected pancreatic cancer based on morphological findings on standard imaging 3)CT, 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 B 1)Male or female =/>18 years old 2)Histological verified carcinoma from the lower oesophagus, 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

Exclusion criteria 1

1. Exclusion criteria for group A 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 or biological composition of [68Ga]Ga-FAPI-46. Exclusion criteria for group B 1)The subject is not considered suitable for diagnostic laparoscopy and potentially curative treatment at the MDT-conference 2)Pregnancy or lactation 3)Weight more than the maximum limit of a PET/CT-scanner bed ( 140 kg) 4)History of allergic reaction due to compounds similar to the chemical or biological composition of [68Ga]Ga-FAPI-46

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB 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).

Secondary endpoints 1

1. 1) Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 TB PET/CT after 60 min, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV) 2) Estimated potential impact/change in patient management 3)Description of FAPI-uptake from lesions suspicious of malignancy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Barbara Malene Fischer

Public contact point

Organisation

Rigshospitalet

Contact name

Barbara Malene Fischer

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications