[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

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

Trial duration

30 Jan 2024 → ongoing

Decision date (initial)

2023-11-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-503632-41-01

WHO UTN

U1111-1287-8331

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)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Inclusion criteria for group A: 1)Male or female, =/>18 years old
2. Inclusion criteria for group A: 2)Patients with suspected pancreatic cancer based on morphological findings on standard imaging
3. Inclusion criteria for group A: 3)CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
4. Inclusion Criteria for group A: 4)Subjects must have been considered suitable for curative surgery at the time of the referral
5. Inclusion criteria for group A: 5)Subjects must be able to read and understand the patient information in Danish to give informed consent
6. Inclusion criteria for group B1: 1)Male or female, =/>18 years old
7. Inclusion criteria for group B1: 2)Histological verified carcinoma from the lower esophagus, GEJ, or stomach
8. Inclusion criteria for group B1: 3)Subjects must be considered operable and resectable at the time of referral for MDT
9. Inclusion criteria for group B1: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent
10. Inclusion criteria for group B2: 1)Male or female, =/>18 years old
11. Inclusion criteria for group B2: 2)Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
12. Inclusion criteria for group B2: 3)Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
13. Inclusion criteria for group B2: 4)Subjects must be able to read and understand the patient information in Danish to give informed consent

Exclusion criteria 3

1. Exclusion criteria for group A+B: 1)Pregnancy or lactation
2. Exclusion criteria for group A+B: 2)Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
3. Exclusion criteria for group A+B: 3)History of allergic reaction due to compounds similar to the chemical 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 3

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. 2) Estimated potential impact/change in patient management.
3. 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

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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