Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung… (NCT07007325) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC)
France15 participantsStarted 2026-09-30
Plain-language summary
\[68Ga\]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by \[68Ga\]Ga-PentixaFor
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
. Written informed consent signed before performing any trial specific procedure.
. Male or female, age ≥ 18 years at time of study entry.
. Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.
. Metastatic disease documented by conventional imaging and/or \[18F\]FDG PET-CT with at least one metastatic measurable lesion (RECIST 1.1). Patients eligible for 1st line metastatic treatment.
. Availability of tissue material (primary lesion and/or metastatic site) to allow additional immunohistochemical studies.
. PS \< 2.
. Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor.
. Adequate Organ function confirmed by laboratory test results allowing for safe the \[68Ga\]Ga-PentixaFor administration.
Exclusion criteria
. History of cancer in the 3 years prior to entry into the trial other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
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.
1This trial uses a new PET scan tracer called [68Ga]Ga-PENTIXAFOR — how does this compare to the standard [18F]FDG PET-CT I would normally get for staging my SCLC, and is there any chance participating could delay starting my treatment?
2Since this is an early Phase 1 study that hasn't started enrolling yet, what does that mean for how much is already known about the safety of this new imaging agent in people with metastatic SCLC like me?
3The trial is focused on comparing how well two different PET scans detect tumors at diagnosis — would taking part actually change which treatments I receive, or is this primarily about gathering imaging data?
4Given that this study is not yet recruiting, is there a realistic timeline for when it might open, and should I go ahead with standard staging and treatment now rather than waiting to see if I could enroll?
5Are there other imaging studies or treatment trials for metastatic SCLC that might be a better fit for my situation right now, especially since this one is specifically focused on diagnostic scanning rather than a new therapy?
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
To evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at diagnosis
. History of anti-cancer treatments such as chemotherapy, radiotherapy or immunotherapy as well as other clinical trials for SCLC before the first \[68Ga\]Ga-PentixaFor PET-CT imaging.
. Inability to lie still for at least 1 hour, or known claustrophobia.
. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic) which may interfere with study objectives or patient safety or compliance, in the judgment of the investigator.
. Unstable diabetes with blood glucose \> 2 g/L.
. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product.
. Body weight of less than 48 kg.
. Mental impairment that may compromise the ability to give informed consent and comply with study requirements.