\[68Ga\]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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Written informed consent signed before performing any trial specific procedure.
2. Male or female, age ≥ 18 years at time of study entry.
3. Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.
4. 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.
5. Availability of tissue material (primary lesion and/or metastatic site) to allow additional immunohistochemical studies.
6. PS \< 2.
7. Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor.
8. Adequate Organ function confirmed by laboratory test results allowing for safe the \[68Ga\]Ga-PentixaFor administration.
9. Life expectancy greater than 3 months.
10. Patient has valid health insurance.
11. Patient willing and able to comply with the protocol throughout the duration of the study, including during treatment and scheduled visits and examinations, including follow-up.
Exclusion Criteria:
1. 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.
2. 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.
3. Inability to lie still for at least 1 hour, or known claustrophobia.
4. 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.
5. Unstable diabetes with blood glucose \> 2 g/L.
6. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product.
7. Body weight of less than 48 kg.
8. Mental impairment that may compromise the ability to give informed consent and comply with study requirements.
9. Pregnant, likely to be pregnant or breastfeeding woman.
10. Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.
11. Disorder preventing understanding of trial information or informed consent.
Primary outcome measure(s)
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 — 30 days The concordance between the two techniques (\[18F\]FDG PET-CT and \[68Ga\]Ga-PentixaFor PET-CT) will be assessed by lesion at diagnosis.
Cohen's Kappa coefficient will be calculated and accompanied by the probability of finding the same lesion on \[68Ga\]Ga-PentixaFor PET-CT knowing that it was present on \[18F\]FDG PET-CT (which may be similar to a measurement of sensitivity).
Trial sites (3)
Facility
City
Region
Status
Institut de cancérologie de l'ouest
Angers
France
CHU d'Angers
Angers
France
Institut de cancérologie de l'ouest
Saint-Herblain
France
More Institut Cancerologie de l'Ouest trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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