The effect of [18F]F-FAPI PET-CT on management in patients with potentially resectable biliary tract cancers: prospective multicenter study and cost-effectivity analysis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Nov 2024 → ongoing

Decision date (initial)

2024-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The primary aim of this study is to assess the diagnostic accuracy of [18F]F-FAPI PET-CT in addition to standard preoperative imaging in patients with potentially resectable proximal bile duct cancer (intrahepatic, perihilar and gall bladder cholangiocarcinoma).

Secondary objectives 7

1. To assess change in therapy due to [18F]F-FAPI PET-CT
2. To assess inter-reader variability between nuclear medicine specialists
3. To evaluate if adding [18F]F-FAPI PET-CT to preoperative imaging is cost-effective
4. To assess the number of additional significant findings on [18F]F-FAPI PET-CT
5. To assess treatment delay between patients with and without significant findings on [18F]F-FAPI PET-CT
6. To assess the safety and tolerability of [18F]F-FAPI PET-CT, biopsy or exploratory surgery
7. To assess if dynamic imaging followed by conventional PET-CT can differentiate between benign and malignant processes

Conditions and MedDRA coding

Cholangiocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)
2. Tumor is regarded as resectable based on preoperative CT and MRI
3. Patient is 18 years or older and is able to give informed consent

Exclusion criteria 9

1. Previous abdominal surgery or chemotherapy
2. Patient had FDG PET-CT in addition to preoperative CT and MRI
3. Contra-indication for performing PET-CT
4. Indication for FDG PET-CT
5. Pregnancy or lactation, for the latter, temporary discontinuation may be considered
6. Known allergic reaction to therapeutic radiopharmaceuticals
7. Inability to lie still on the back for the duration of PET-CT
8. Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
9. Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. sensitivity, specificity, positive predictive value, negative predictive value

Secondary endpoints 7

1. True change and virtual change
2. Number of times readers’ conclusions differed
3. Cost-effectiveness analysis, budget impact analysis (BIA), sector costs, societal costs, health-related quality of life (HRQoL)
4. Number of additional significant findings
5. Number of days between date of first imaging (CT/MRI) and starting date of chemotherapy, palliative therapy or surgical resection
6. The incidence and severity of AEs and SAEs according to CTCAEv5
7. Volume of interest (VOI), time to peak(TTP), K1 and K2, standardize uptake value (SUV), tumor-to-background ratio (TBR)

Investigational products

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

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Dr. Maarten Thomeer

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Dr. Maarten Thomeer

Locations

1 EU/EEA country · 3 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 5 files

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

Application history

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