Authorised Human Pharmacology (Phase I)- Other triple-negative breast cancer

ProspectivE phase 0 pilot study, assessing potential prognostic and theranostic interest of 68Ga-PentiXafor PET-CT In metastatic triple neGative brEast caNCer patiEnts (EXIGENCE)

EU CTIS ID: 2024-517658-90-00

What this study is testing

To assess the concordance for tumor lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion.

Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1) Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
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
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
Metastatic status documented by [18F]FDG PET/CT ± conventional imaging with at least one evaluable metastasis in [18F]FDG PET/CT according to PERCIST

You likely can't join if

1) History of another primary malignancy within the last 3 years except for basal cell carcinoma.
10) Body weight of less than 48 kg
11) Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
12) Disorder precluding understanding of trial information or informed consent
2) Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration
3) Impossibility to hold lying motionless at least 1 hour, or known claustrophobia

See the full eligibility criteria

Who can join

1) Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
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
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
Metastatic status documented by [18F]FDG PET/CT ± conventional imaging with at least one evaluable metastasis in [18F]FDG PET/CT according to PERCIST
5) ECOG performance status < 2.
6) Negative serum/urine pregnancy test prior to [68Ga]Ga-PentixaFor administration.
7) Consent to use a contraception method for at least 3 months after each administration of [68Ga]Ga-PentixaFor.
8) Adequate Organ function confirmed by laboratory tests results allowing for safe administration of [68Ga]Ga-PTF
9) Life expectancy at least 3 months.

What rules you out

1) History of another primary malignancy within the last 3 years except for basal cell carcinoma.
10) Body weight of less than 48 kg
11) Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian
12) Disorder precluding understanding of trial information or informed consent
2) Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first [68Ga]Ga-PTF administration
3) Impossibility to hold lying motionless at least 1 hour, or known claustrophobia
4) 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
5) Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
6) Pregnant, likely to be pregnant or breastfeeding woman
7) Unstable diabetes with blood glucose > 2 g/L
8) Renal insufficiency with GFR ≤ 45 mL/min/ 1.73 m².
9) Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PentixaFor and/or [18F]FDG product

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.