New imaging agent could spot Hard-to-Treat breast cancer spread
NCT ID NCT06962163
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing a new type of PET scan that uses a tracer called [68Ga]Ga-PentixaFor to see if it can detect metastatic triple-negative breast cancer as well as or better than the standard FDG PET scan. The study will enroll 12 patients with metastatic triple-negative breast cancer. Each patient will receive the new scan at the start of the study and again if their disease progresses. The goal is to see if this imaging method can identify tumors that have high levels of a protein called CXCR4, which could make them candidates for future targeted therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [68Ga]Ga-PentixaFor (a radioactive tracer for PET/CT imaging)
- What this could lead to
- If successful, this imaging method could help identify patients whose tumors have high CXCR4 levels, potentially guiding them to more targeted treatments in the future.
- What could go wrong
- This is a very early pilot study with only 12 participants, so results may not apply to all patients. The scan is for research purposes only and will not directly treat the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations. 2. Female or male, Age ≥ 18 years at time of study entry. 3. Primitive triple negative breast cancer proven histologically, defined according to the following criteria: * Estrogen receptors \<10%. * And progesterone receptors \<10%. * And HER2 not amplified or not overexpressed. 4. Recurrence metastatic Breast Cancer or De Novo metastatic Breast Cancer documented by \[18F\]FDG PET/CT ± conventional imaging with at least one measurable metastasis according to PERCIST and/or RECIST. 5. ECOG performance status \< 2. 6. Negative serum/urine pregnancy test prior to \[68Ga\]Ga-PentixaFor administration for female patient of childbearing potential\*. 7. Consent to use a contraception method for at least 3 months after each administration of \[68Ga\]Ga-PentixaFor (as defined in Appendix 7 and according to local guidelines). 8. Adequate Organ function confirmed by laboratory tests results allowing for safe administration of \[68Ga\]Ga- PentixaFor: Hematologic function: Absolute Neutrophil Count (ANC) of ≥ 1.5 x 109 /L, platelet count of ≥ 100 x 109 /L, and hemoglobin of ≥ 9 g/dL). Hepatic function: AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases). 9. Renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m², as calculated using the CKD-EPI or MDRD equation.Life expectancy at least 3 months. 10. Patient has valid health insurance. 11. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Note: a female participant of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause). Exclusion Criteria: 1. History of another primary malignancy within the last 3 years before study entry except for basal cell carcinoma. 2. Impossibility to hold lying motionless at least 1 hour, or known claustrophobia. 3. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator. 4. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 5. Pregnant, likely to be pregnant or breastfeeding woman. 6. Blood glucose \> 12mmol/L. 7. Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m². 8. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PentixaFor and/or \[18F\]FDG product. 9. Body weight of less than 48 kg. 10. Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian. 11. Disorder precluding understanding of trial information or informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institut de cancerologie de l'Ouest
RECRUITINGSaint-Herblain, 44805, France
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