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New treatment option for Locally Advanced Gastric Adenocarcinoma
Official title [18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT07018661
What this study is testing
What is [18F]-FAPI-74?
[18F]-FAPI-74 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced gastric adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if a new type of scan, FAPI-PET/CT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy;
- Age greater than or equal to 18 years;
- Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to...
- Patients must have given written informed consent;
- Patients who have recently participated in an treatment study with an investigational medicinal product (IMP) may only participate if an interaction...
You likely can't join if
- Siewert type I-II esophagogastric junction tumor;
- Unfit or unwilling to undergo study procedures;
- Unfit or unwilling to undergo surgery;
- Pregnancy at time of the [18F]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden;
- Incapacitated people without decision-making capacity;
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
See the full eligibility criteria
- Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy;
- Age greater than or equal to 18 years;
- Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and...
- Patients must have given written informed consent;
- Patients who have recently participated in an treatment study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based...
- Siewert type I-II esophagogastric junction tumor;
- Unfit or unwilling to undergo study procedures;
- Unfit or unwilling to undergo surgery;
- Pregnancy at time of the [18F]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden;
- Incapacitated people without decision-making capacity;
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
- Illiterate patients unable to complete the resource use and quality of life questionnaires;
- Inability to undergo PET/CT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).
The study team makes the final eligibility decision.
Where it's taking place
- Almelo, Netherlands
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Eindhoven, Netherlands
- Geleen, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almelo, Netherlands; Amsterdam, Netherlands; Arnhem, Netherlands; Eindhoven, Netherlands; Geleen, Netherlands; Groningen, Netherlands and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.