Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC) at Diagnosis and Disease Progression
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
Brief 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
Detailed Description
Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancers, but remains a cancer with a poor prognosis, often detected at a metastatic stage and associated with a high rate of early recurrence.
Therapeutic options for unresectable SCLC are limited and essentially rely on first-line radiochemotherapy for limited disease or chemo-immunotherapy, possibly supplemented by radiotherapy, for extensive disease.
CXCR4 is a chemokine receptor that is highly expressed in this cancer. By targeting CXCR4 with [177Lu]Lu-PentixaTher or [90Y]Y-PentixaTher, patients with SCLC could benefit from a new type of treatment in this indication: Peptide Receptor Radionuclide Therapy (PRRT).
However, there is a need for a preliminary diagnostic study due to a lack of published data.
[68Ga]Ga-PentixaFor is an experimental compound that binds with high affinity to CXCR4 and appears to be a promising candidate for PET-CT imaging of SCLC. This initial step is crucial to confirm CXCR4 targeting by [68Ga]Ga-PentixaFor before considering PRRT with therapeutic radionuclides such as Lu-177 or Y-90 in future trials.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
- •Life expectancy greater than 3 months.
- •Patient has valid health insurance.
- •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
- •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.
- •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.
- •Pregnant, likely to be pregnant or breastfeeding woman.
- •Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.
- •Disorder preventing understanding of trial information or informed consent.
Arms & Interventions
[68Ga]Ga-PentixaFor
The patient receives a single dose I.V. injection of [68Ga]Ga-PentixaFor 150 (± 50) MBq, corresponding to a peptide mass dose of ≤ 50 μg per administration.
Intervention: [68Ga]Ga-PentixaFor (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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).
Secondary Outcomes
- Evaluate the diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.(24 months)
- Description of the evolution of [68Ga]Ga-PentixaFor PET-CT data obtained at diagnosis and at disease progression time at the patient level.(24 months)
- 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.(24 months)
- Evaluate the correlation between semi-quantitative data of [68Ga]Ga-PentixaFor PET-CT with CXCR4 expression on biopsies, assessed by immunohistochemistry (IHC).(24 months)
- Describe the lesions identified by [68Ga]Ga-PentixaFor PET-CT and by [18F]FDG PET-CT.(24 months)
- Compare the number of lesions detected by [18F]FDG PET-CT and those detected by [68Ga]Ga-PentixaFor PET-CT.(24 months)
- Assess safety profile of [68Ga]Ga-PentixaFor.(24 months)