Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Re… (NCT06876532) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour
France150 participantsStarted 2025-04-07
Plain-language summary
This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors.
This IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:
* IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment).
* IBI \> 0, including: IBI = 1: Intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated CRP)); IBI = 2: High mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated CRP)).
Patients were followed up for 36 months.
A total of 150 patients should be included in this study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient aged ≥ 18 years.
. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.
. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.
. Evidence of progression in the 12 months preceding Lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic CT and/or liver MRI, Ga-68 DOTA somatostatin analog PET-CT) +/- liver involvement greater than 50%.
. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +/- liver MRI.
. Patient affiliated to a social security scheme in France.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity, defined as the ratio of the number of refractory patients with an IBI score > 0 to the number of refractory patients.
Timeframe: 12 months for each patient
2
Specificity, defined as the ratio of the number of non-refractory patients with an IBI score = 0 to the number of non-refractory patients.
. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.
Exclusion criteria
. Previous treatment with Lu-177 oxodotreotide.
. Any contraindication to treatment with Lu-177 oxodotreotide.
. Morbid obesity (BMI \> 40).
. Uncontrolled/unbalanced active inflammatory disease in the 3 months prior to inclusion.
. Active carcinoid heart disease or other acute cardiovascular event.
. Active infection not treated within 15 days.
. Pregnant or breast-feeding woman.
. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.