\[68Ga\]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
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.
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.
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.
Single group
[68Ga]Ga-PentixaFor
Drug\[68Ga\]Ga-PentixaFor PET-CT
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
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).
Evaluate the concordance of tumoral lesions detected between [68Ga]Ga-PentixaFor PET-CT and [18F]FDG PET-CT, considered as the reference, performed at disease progression.
The concordance between the two techniques (\[18F\]FDG PET-CT and \[68Ga\]Ga-PentixaFor PET-CT) will be assessed by lesion at disease progression. 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).
Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.
The diagnostic performances will be assessed using the Specificity, at diagnosis time on one hand, and at disease progression time on the other hand.
Evaluate the correlation between semi-quantitative data of [68Ga]Ga-PentixaFor PET-CT with CXCR4 expression on biopsies, assessed by immunohistochemistry (IHC).
The correlation between the standardized uptake values (SUV) of \[68Ga\]Ga-PentixaFor -positive lesions and the biological expression of CXCR4 will be described by Spearman's ρ, at diagnosis and at disease progression time if data are available.
Describe the lesions identified by [68Ga]Ga-PentixaFor PET-CT and by [18F]FDG PET-CT.
The qualitative analysis will focus on lesion description in each major organ (lung, lymph node, bone marrow, brain...). Quantitative analysis will focus on continuous parameters at the lesion level (SUV, MTV, TLG and tumour-to-background ratio, etc.). The detection rate of tumour lesions will be calculated. This analysis will be conducted for each radiotracer at diagnosis time on one hand, and at disease progression time on the other hand.
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