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Pilot study for the evaluation of [68Ga]Ga-PentixaFor PET imaging for the identification of unilateral adrenal secretion of ALdosterON in patients with primary aldosteronism.
EU CTIS ID: 2023-505507-22-00
What this study is testing
To evaluate whether [68Ga]Ga-PTF-PET imaging allows for the discrimination of patients with lateralized or non-lateralized secretion of aldosterone in adrenal glands classified based on AVS.
- Phase II and Phase III (Integrated)
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
- Age ≥ 18 years old
- Signed written informed consent
- French Social Security affiliation
- For child-bearing aged women, efficient contraception
- Diagnosis of primary aldosteronism: - With or without adrenal nodule on morphological imaging (CT or Magnetic Resonance Imaging) - With unilateral or bilateral aldosterone secretion confirmed by invasive AVS
You likely can't join if
- Pregnant or breastfeeding women
- Patient under legal protection (guardianship)
- Contraindication to the PET-CT
- Contraindication to the injection of [68Ga]Ga-PentixaFor
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Patient on AME (state medical aid) (unless exemption from affiliation)
See the full eligibility criteria
- Age ≥ 18 years old
- Signed written informed consent
- French Social Security affiliation
- For child-bearing aged women, efficient contraception
- Diagnosis of primary aldosteronism: - With or without adrenal nodule on morphological imaging (CT or Magnetic Resonance Imaging) - With unilateral or bilateral aldosterone secretion confirmed by invasive AVS
- Pregnant or breastfeeding women
- Patient under legal protection (guardianship)
- Contraindication to the PET-CT
- Contraindication to the injection of [68Ga]Ga-PentixaFor
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Patient on AME (state medical aid) (unless exemption from affiliation)
- Completed group: if the expected number of patients has been reached (15 patients) in the corresponding group of patients (with lateralized or non-lateralized PA).
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.
Explore other conditions
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.