The Value of 68Ga-FAPI PET/CT for Evaluating Peritoneal Treatment Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ⁶⁸Ga-FAPI-46.
- Who it may be relevant to
- Registry conditions: Peritoneal Metastasis, FAPI. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Peritoneal metastases (PM), commonly originating from gastrointestinal and ovarian cancers, are associated with a poor prognosis and limited treatment options due to the diffuse nature of the disease and the inability of systemic chemotherapy to adequately penetrate the peritoneal surface. Intraperitoneal (IP) chemotherapy has emerged as a potential treatment modality for patients with extensive PM, allowing for higher local drug concentrations while minimizing systemic toxicity. However, current response evaluation methods, such as CT scans, have low sensitivity for detecting PM, and second-look laparoscopy, although more accurate, is invasive and unsuitable for repeated assessments. The ⁶⁸Ga-FAPI PET/CT scan offers a promising non-invasive alternative for assessing peritoneal response to IP chemotherapy. This imaging technique targets the fibroblast activation protein, which is overexpressed in cancer-associated fibroblasts within the tumor microenvironment. Early studies have shown that ⁶⁸Ga-FAPI PET/CT is a highly sensitive too in detecting peritoneal metastases. Given these advantages, the investigators hypothesize that ⁶⁸Ga-FAPI PET/CT could improve the evaluation of treatment response in patients undergoing IP chemotherapy for PM, offering a non-invasive and accurate alternative to current methods. The primary objective of this study is to investigate the accuracy of ⁶⁸Ga-FAPI PET/CT for evaluating peritoneal response in patients with peritoneal metastases undergoing repeated IP chemotherapy.
Interventions
- Drug ⁶⁸Ga-FAPI-46
All patients will be administered with 1.5 MBq/kg ⁶⁸Ga-FAPI-46. ⁶⁸Ga-FAPI-46 will be injected intravenously followed by a flush injection of 10 mL of saline following routine procedures.
Primary outcome measures
- Accuracy of ⁶⁸Ga-FAPI [Time frame: 18 weeks]
Secondary outcome measures (1)
- Tumor response to IP chemotherapy [Time frame: 18 weeks]
Eligibility criteria
Inclusion criteria
- A planned start of repeated IP chemotherapy (with or without the combination of systemic chemotherapy) for macroscopic peritoneal metastases;
- WHO-performance score of 0 to 1;
- Aged 18 years or older;
- Written informed consent according to the ICH-GCP and national/local regulations.
Exclusion criteria
- Impaired renal function, defined as eGFR <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician;
- Pregnancy/breastfeeding. 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;
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06957782 · 2024-520037-76-00