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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ⁶⁸Ga-FAPI-46 | Experimental | ⁶⁸Ga-FAPI-46 will be used as a diagnostic tracer for PET/CT to image peritoneal tumor cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ⁶⁸Ga-FAPI-46 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of ⁶⁸Ga-FAPI | To investigate the accuracy of the ⁶⁸Ga-FAPI PET/CT for peritoneal response evaluation in patients with peritoneal metastases that are treated with any form of repeated IP chemotherapy. The accuracy will be calculated as the sensitivity and specificity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as a reference standard. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response to IP chemotherapy | To measure the tumor response to IP chemotherapy. The absolute change in peritoneal tumor size or volume as measured by imaging before and after treatment. | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Micha de Neijs | Contact | +31 10 70 39640 | m.deneijs@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Stijn Koolen, PharmD, PhD | Erasmus Medical Center | Principal Investigator |
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This is a non-randomized, single center, investigator-initiated, proof-of-concept, prospective imaging study
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