Clinical trial

The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.

Name

H-20027060

Description

A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green. Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.

Trial arms

Trial start

2022-03-11

Estimated PCD

2023-12-29

Trial end

2023-12-30

Status

Terminated

Phase

Early phase I

Treatment

Indocyanine green

A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG (quantitative perfusion assessments with ICG) to obtain baseline perfusion values.

Arms:

ICG patient

Size

Primary endpoint

Difference in gastric perfusion

2 years

Eligibility criteria

Inclusion Criteria: * Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer. Exclusion Criteria: * Allergy towards; iodine, indocyanine green or shellfish * Severe liver insufficiency * Thyrotoxicosis * Nephropathy requiring dialysis * Pregnancy or lactation * Legally incompetent for any reason * Withdrawal of inclusion consent * Disseminated disease or other that contraindicates curative surgery

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Only patients with resectable gastric cancer are included in the study', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

Updated at

2024-05-02

1 organization

1 product

1 indication

Organization

Rigshospitalet

Product

Indocyanine green

Indication

Stomach Cancer