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PASSIFLORE[68Ga]Ga-PENTIXAFOR PET-CT for Metastatic Small Cell Lung Cancer Diagnosis

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What is being tested

[68Ga]Ga-PentixaFor

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorInstitut Cancerologie de l'Ouest
Study ContactMarie LACOMBE, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2025

Actual date on which the first participant was enrolled.

This study aims to explore a new method for diagnosing small cell lung cancer (SCLC), which is a fast-growing type of lung cancer often found at an advanced stage. Current treatments are limited, especially when the cancer has spread. Researchers are investigating a specific receptor, CXCR4, which is often present in this cancer type. By using a compound named [68Ga]Ga-PentixaFor in a PET-CT scan, scientists hope to better visualize the cancer, potentially leading to new treatment options in the future, such as Peptide Receptor Radionuclide Therapy (PRRT). Participants in the study will undergo PET-CT scans using the experimental compound [68Ga]Ga-PentixaFor. This compound attaches to the CXCR4 receptor in the cancer cells, allowing doctors to see how the cancer behaves and spreads. The study does not involve any treatment but is crucial in confirming whether this new imaging technique can accurately target the cancer. If successful, it could pave the way for future studies that might offer new treatment methods for patients with this challenging type of lung cancer.

Official TitleProspective 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
Principal SponsorInstitut Cancerologie de l'Ouest
Study ContactMarie LACOMBE, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

11 inclusion criteria required to participate
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.
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11 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Institut de cancérologie de l'ouest

Angers, FranceOpen Institut de cancérologie de l'ouest in Google Maps
Suspended

CHU d'Angers

Angers, France
Suspended

Institut de cancérologie de l'ouest

Saint-Herblain, France
Recruiting soon3 Study Centers