68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging after Chemotherapy in Patients with Gastric and Gastro-Esophageal Junctional Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aalborg University Hospital

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

15 Feb 2024 → 18 Dec 2025

Decision date (initial)

2023-11-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alfred Benzon Foundation · The department of Nuclear Medicine, Aalborg University Hospital · The North Jutland Health Science Research Foundation

External identifiers

EU CT number

2023-505916-40-01

ClinicalTrials.gov

NCT05898854

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety

1. Compare the diagnostic accuracy of FAPI PET/CT to FDG PET/CT on a lesion basis at primary staging and restaging (after neoadjuvant chemotherapy)
2. Compare the FAPI PET/CT to FDG PET/CT tentative staging at primary staging and restaging (after neoadjuvant chemotherapy)
3. Investigate the feasibility of FAPI PET/CT at restaging (after chemotherapy)
4. Explore the potential limitations of FAPI PET/CT in tumor deposits

Secondary objectives 7

1. Investigate the FAPI uptake in tumor deposits
2. Investigate the feasibility of FAPI PET/CT in chemotherapy response assessment compared to FDG PET/CT
3. Investigate the prognostic value of FAPI PET/CT compared to FDG PET/CT at primary staging and restaging
4. Evaluate potential unexpected FAPI PET/CT findings
5. Estimate the interobserver agreement.
6. Investigate the safety of [68Ga]Ga-FAPI-46 injection
7. Evalute FAPI PET/CTs impact on patient management

Conditions and MedDRA coding

Gastroesophageal junction cancer (GEJ-cancer)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Newly diagnosed with biopsy verified gastric or GEJ cancer and referred to primary staging FDG PET/CT
2. Deemed resectable and operable at the MDT, with or without neoadjuvant chemotherapy
3. Considered physically and mentally able to participate in the research project
4. Can read and understand Danish
5. 18-years or older and able to consent to project participation

Exclusion criteria 11

1. Patients with non-resectable, inoperable, or recurrent gastric or GEJ cancer
2. Patients with an imminent need for surgery or in an emergency
3. Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer
4. Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
5. Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
6. History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46
7. Severe claustrophobia unresponsive to oral anxiolytics
8. Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study
9. Pregnant, lactating, or breastfeeding women
10. Fertile women (women of childbearing potential) not using effective contraceptives (definitions i protocol). Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG) or serum HCG) < 48 hours before injection with 68Ga-FAPI-46
11. Inability to remain still for the duration of the examination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, positive predicative value, and negative predicative values of the PET/CTs are determined, both at primary staging and at restaging
2. Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging and at restaging (after neoadjuvant chemotherapy). The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/CT are determined.
3. Investigate the feasibility of FAPI PET/CT at restaging (after neoadjuvant chemotherapy) by comparing the FAPI PET/CT signal after neoadjuvant chemotherapy to a histopathological reference standard
4. Investigate the correlation between FAPI PET/CT SUV values and extent of FAP expressing CAFs in tumor deposits through volume-density estimation and immunohistochemical assessment of surgical specimens.

Secondary endpoints 9

1. SUV and TBR values for primary, regional lymph nodes, and distant metastases for FAPI PET/CT and compare these values to FDG PET/CT, both at primary staging and at restaging (after neoadjuvant chemotherapy)
2. Changes in SUV and TBR in primary, regional lymph nodes, and distant metastases for FAPI PET/CT - from before to after neoadjuvant chemotherapy and compare these values to the FDG PET/CT parameters.
3. MTV and TLG for both FAPI PET/CT and FDG PET/CT at primary and restaging (after neoadjuvant chemotherapy) and compare these values between FAPI PET/CT and FDG PET/CT.
4. Changes in MTV and TLG for both FAPI PET/CT and FDG PET/CT from before to after neoadjuvant chemotherapy and compare these values between FAPI PET/CT and FDG PET/CT.
5. Seek supplementary information in medical records, biochemistry, pathology, or other imaging modalities for a final diagnosis/condition in cases of unexpected FAPI PET/CT findings not related to the known cancer
6. Correlate the FAPI PET/CT results/staging of patients to the actual clinical outcome and compare these to the FDG PET/CT results/staging. RFS and OS will be determined.
7. Conduct an interobserver study of FAPI PET/CTs performed in the present and other future FAPI PET/CT in cancers studies.
8. Investigate what proportion of patients will be (hypothetically) treated differently due to an added FAPI PET/CT at primary staging and at restaging (after neoadjuvant chemotherapy) by the treating clinicians
9. Note reported discomfort, and measure heart rate and blood pressure before and at specific timepoints after FAPI infusion.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aalborg University Hospital

Sponsor organisation

Aalborg University Hospital

Address

Hobrovej 18/22

City

Aalborg

Postcode

9000

Country

Denmark

Scientific contact point

Organisation

Aalborg University Hospital

Contact name

Helle D. Zacho

Public contact point

Organisation

Aalborg University Hospital

Contact name

Helle D. Zacho

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 6 files

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

Application history

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