The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma

NCT06355427 | Recruiting Phase 2

• 1 other identifier: 2023-507938-24-00
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

Brief Summary

Background Bile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher accuracy than those currently used. Single center studies have shown that fibroblast activation protein inhibitor (FAPI) PET-CT is a very promising technique for determining metastases in tumors with prominent desmoplastic reactions, like cholangiocarcinoma. The investigators predict that implementation of preoperative FAPI PET-CT could prevent futile surgery for at least half of patients in whom intra-operative metastasized disease is found using the current work-up. Patient population Patients ≥18 years with potentially curable proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma) who are planned to undergo surgery based on imaging using CT thorax/abdomen and MRI of the upper abdomen. Exclusion criteria are previous abdominal surgery or chemotherapy, known pregnancy or lactation and indication for FDG PET-CT. Participation in this study Participation would mean to undergo FAPI PET-CT prior to the scheduled surgery. This will take up about half a day of the participant's time. Afterwards, participants receive questionnaires about quality of life and use of healthcare services over a period of six months in order for the researchers to be able to calculate the cost-effectiveness of additional FAPI PET-CT. Risks and benefits of participation Patients may benefit directly from \[18F\]F-FAPI PET-CT by allowing for more targeted treatment, possibly avoiding futile surgery and receiving chemotherapy or best clinical support instead, minimizing treatment delay. Avoiding futile surgery will also prevent patients from being exposed to the risks and discomfort associated with surgery: hospital stay, possibility of intraoperative or postoperative complications, postoperative pain and recovery, and mortality. Potential risks and burdens associated with this study are an extra hospital visit and a time burden of approximately half a day. Risks associated with administering FAPI are (re)bleed and infection. Both risks have a minimal probability of onset and can usually easily be treated. As \[18F\]F-FAPI is a sub-pharmacologically micro-dosed diagnostic tracer, the risk of allergic reactions is expected to be minimal and no tissue damage is expected. The burden associated with undergoing a PET-CT may be laying still for a certain time, and possible experience of claustrophobia. Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants will have to undergo additional testing such as imaging (CT or MRI) or biopsy. Undergoing FAPI PET-CT prior to surgery will result in a surgical delay when compared with the current clinical practice. The investigators do not expect this delay to influence the patient's prognosis. Follow-up will result in a time burden for patients to answer questionnaires on a two-weekly or monthly basis.

Conditions

Cholangiocarcinoma

Keywords

FAPI; Cholangiocarcinoma; FAPI PET/CT; Fibroblast Activation Protein Inhibitor; Proximal cholangiocarcinoma; FAPIChol; PET/CT; 18F-FAPI-74

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of [18F]F-FAPI PET-CT

  Diagnostic accuracy will be expressed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)

  Six months following PET-CT

Secondary Outcomes (12)

• Change of treatment

  Within one month following PET-CT

• Cost-effectiveness

  Six months following PET-CT

• Number of additional significant findings using [18F]F-FAPI PET-CT

  Within one week after PET-CT

• Number of times nuclear medicine specialists' [18F]F-FAPI PET-CT conclusions differed from one another

  Within one week after PET-CT

• Number of lesions found on [18F]F-FAPI PET-CT

  Within one week after PET-CT

Study Arms (1)

FAPI PET-CT

EXPERIMENTAL

Participants will undergo additional FAPI PET-CT prior to scheduled surgery.

Drug: [18F]F-FAPI PET-CT

Interventions

[18F]F-FAPI PET-CT DRUG

\[18F\]F-FAPI PET-CT in addition to regular CT and MRI, prior to participants undergoing surgery

FAPI PET-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous abdominal surgery or chemotherapy
• Patient had FDG PET-CT in addition to preoperative CT and MRI
• Contra-indication for performing PET-CT
• Indication for FDG PET-CT
• Pregnancy or lactation, for the latter, temporary discontinuation may be considered.
• Known allergic reaction to therapeutic radiopharmaceuticals
• Inability to lie still on the back for the duration of PET-CT
• Impaired renal function, defined as eGFR (MDRD) \<25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
• 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)

Sponsors & Collaborators

• Mara Veenstra, MD: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• UMC Utrecht: collaborator

Study Sites (3)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Mara Veenstra, M.D.

CONTACT

+31 (0)10 704 2006; m.m.k.veenstra@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 9, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (3)