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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

12 Sep 2024 → ongoing

Decision date (initial)

2024-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AP-HP · PentixaPharm

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 8

1. To study the correlation between the ratio of SUVmax on [68Ga]Ga-PTF-PET imaging between the hypersecreting adrenal gland and the contralateral adrenal gland and the lateralization index during AVS
2. To measure the correlation between the ratio of SUVmax on [68Ga]Ga-PTF-PET imaging between both adrenal glands and mean SUVmax of the liver on [68Ga]Ga-PTF-PET imaging
3. To study the association between the ratio of SUVmax on [68Ga]Ga-PTF-PET imaging between the hypersecreting adrenal gland and the contralateral adrenal gland and the evolution of aldosterone secretion after surgical adrenalectomy (persistence or not of PA).
4. To study the association between SUVmax measured on [68Ga]Ga-PTF-PET imaging in the hypersecreting adrenal gland and CXCR4 expression by immuno-histochemistry (immunoreactive score or percentage of positive cells)..
5. To measure the correlation between SUVmax and SUVmean measured on [68Ga]Ga-PTF-PET imaging in the hypersecreting adrenal gland and the size of the adenoma on CT and histology.
6. To analyze the safety and tolerance of [68Ga]Ga-PentixaFor injections.
7. To study the association between SUVmax measured on [68Ga]Ga-PTF-PET imaging in the hypersecreting adrenal gland and CYP11B2 expression by immuno-histolochemistry (immunoreactive score or percentage of positive cells).
8. To study the correlation between the primary endpoints and the mutation status of the adenomas

Conditions and MedDRA coding

Primary aldosteronism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age ≥ 18 years old
2. Signed written informed consent
3. French Social Security affiliation
4. For child-bearing aged women, efficient contraception
5. 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

Exclusion criteria 7

1. Pregnant or breastfeeding women
2. Patient under legal protection (guardianship)
3. Contraindication to the PET-CT
4. Contraindication to the injection of [68Ga]Ga-PentixaFor
5. 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
6. Patient on AME (state medical aid) (unless exemption from affiliation)
7. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Higher SUVmax between both adrenal glands on [68Ga]Ga-PTF-PET imaging
2. Ratio between SUVmax of both adrenal glands on [68Ga]Ga-PTF-PET imaging calculated as higher SUVmax / lower SUVmax of each adrenal gland
3. Difference between SUVmax of both adrenal glands on [68Ga]Ga-PTF-PET imaging calculated as the difference higher SUVmax - lower SUVmax of each adrenal gland
4. Ratio between the higher SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging

Secondary endpoints 10

1. Aldosterone-to-cortisol ratio between the two adrenal veins on AVS (objective 1)
2. Lateralization index during AVS (objective 1),
3. Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging (objective 2),
4. Secretion of aldosterone assessed with blood test after surgical adrenalectomy, dichotomized into persistence of PA at 6 months yes/no (objective 3),
5. CXCR4 expression levels by immuno-histochemistry (immunoreactive score or percentage of positive cells) (objective 4),
6. Adenoma sizes on CT and histology (objective 5)
7. Safety and tolerance of [68Ga]Ga-PentixaFor injections (objective 6)
8. Serious adverse events (any cause).
9. CYP11B2 expression levels by immuno- histochemistry (immunoreactive score or percentage of positive cells) (objective 7)
10. Somatic mutation status of hypersecreting adrenal glands and APA (objective 8).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Fabien HYAFIL (Coordinating investigator)

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

EL AAMRI

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications