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

NCT07007325 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ICO-2023-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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

Conditions

Small Cell Lung Carcinoma (SCLC)

Keywords

Small Cell Lung Carcinoma (SCLC); [68Ga]Ga-PentixaFor; immunohistochemistry (IHC); CXCR4 expression; [18F]FDG; Safety

Outcome Measures

Primary Outcomes (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

  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).

  30 days

Secondary Outcomes (10)

• 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 diagnostic performances of [68Ga]Ga-PentixaFor PET-CT compared to [18F]FDG PET-CT considered as the reference.

  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

Study Arms (1)

[68Ga]Ga-PentixaFor

EXPERIMENTAL

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.

Drug: [68Ga]Ga-PentixaFor

Interventions

[68Ga]Ga-PentixaFor DRUG

\[68Ga\]Ga-PentixaFor PET-CT

[68Ga]Ga-PentixaFor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (3)

Institut de cancérologie de l'ouest

Angers, 49055, France

Location

CHU d'Angers

Angers, 49100, France

Location

Institut de cancérologie de l'ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marie LACOMBE, MD

CONTACT

+33 241352700; Marie.Lacombe@ico.unicancer.fr

Nadia ALLAM, PhD

CONTACT

+33 2 40 67 98 26; nadia.allam@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: June 5, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

FR (3)