Evaluation of [68Ga]Ga-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism

NCT06478875 | Not Yet Recruiting Phase 2

• 2 other identifiers: APHP2208812023-505507-22-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

PentixaFor radiolabeled with 68Gallium (68Ga) is a radiopharmaceutical targeting the CXC chemokine receptor 4 (CXCR4) receptor. The CXCR4 receptor is expressed in zona glomerulosa of the adrenal cortex and in aldosterone producing adenoma (APA). The objective of this study will be to evaluate in 25 patients if \[68Ga\]Ga-PentixaFor positron emission tomography (\[68Ga\]Ga-PTF-PET) imaging allows for the discrimination of patients with lateralized or non-lateralized secretion of aldosterone in adrenal glands classified based on adrenal vein sampling (AVS).

Conditions

Primary Aldosteronism

Keywords

[68Ga]Ga-PentixaFor positron emission tomography; adrenal vein sampling; unilateral adrenal secretion

Outcome Measures

Primary Outcomes (1)

• relevant biomarkers strongly associated with primary lateralized hyperaldosteronism

  * Highest max. standardized uptake value (SUVmax) between both adrenal glands on \[68Ga\]Ga-PTF-PET imaging; * Ratio between SUVmax of both adrenal glands on \[68Ga\]Ga-PTF-PET imaging calculated as highest SUVmax / lowest SUVmax of each adrenal gland; * Difference between SUVmax of both adrenal glands on \[68Ga\]Ga-PTF-PET imaging calculated as the difference highest SUVmax - lowest SUVmax of each adrenal gland; * Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on \[68Ga\]Ga-PTF-PET imaging

  30 days after inclusion

Secondary Outcomes (9)

• Aldosterone-to-cortisol ratio between the two adrenal veins on AVS

  at inclusion

• Lateralization index during AVS

  at baseline (during AVS day)

• Ratio between the highest SUVmax among both adrenal glands and mean SUV of the liver on [68Ga]Ga-PTF-PET imaging

  30 days after inclusion

• Proportion of patients with persistence of PA

  6 months after surgical adrenalectomy

• CXCR4 expression levels by immuno-histology highest CXCR4 density

  6 months after surgical adrenalectomy

Study Arms (1)

[68Ga]Ga-PentixaFor; single injection

OTHER

\[68Ga\]Ga-PentixaFor; 150 (± 50) MBq intravenous injection over 30 seconds; single injection

Combination Product: [68Ga]Ga-PentixaFor PET imaging

Interventions

[68Ga]Ga-PentixaFor PET imaging COMBINATION_PRODUCT

PET imaging of adrenal glands

[68Ga]Ga-PentixaFor; single injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Signed written informed consent
• French Social Security affiliation
• For child-bearing aged women, effective form of 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
• Such methods include: combined hormonal contraception, progestogen-only hormonal contraception, intrauterine device (IUD) or hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, condom, sexual abstinence.

You may not qualify if:

• Pregnant or breastfeeding women
• Patient under legal protection (guardianship)
• Contraindication to the PET-CT
• Contraindication to the injection of \[68Ga\]Ga-PentixaFor
• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pentixapharm AG: collaborator

Study Sites (2)

hôpital Cochin

Paris, 75014, France

Location

Hôpital européen Georges Pompidou - APHP

Paris, 75015, France

Location

Related Publications (18)

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  PMID: 32890264 BACKGROUND

• Amar L, Baguet JP, Bardet S, Chaffanjon P, Chamontin B, Douillard C, Durieux P, Girerd X, Gosse P, Hernigou A, Herpin D, Houillier P, Jeunemaitre X, Joffre F, Kraimps JL, Lefebvre H, Menegaux F, Mounier-Vehier C, Nussberger J, Pagny JY, Pechere A, Plouin PF, Reznik Y, Steichen O, Tabarin A, Zennaro MC, Zinzindohoue F, Chabre O. SFE/SFHTA/AFCE primary aldosteronism consensus: Introduction and handbook. Ann Endocrinol (Paris). 2016 Jul;77(3):179-86. doi: 10.1016/j.ando.2016.05.001. Epub 2016 Jun 15.

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  PMID: 27789718 BACKGROUND

• Bluemel C, Hahner S, Heinze B, Fassnacht M, Kroiss M, Bley TA, Wester HJ, Kropf S, Lapa C, Schirbel A, Buck AK, Herrmann K. Investigating the Chemokine Receptor 4 as Potential Theranostic Target in Adrenocortical Cancer Patients. Clin Nucl Med. 2017 Jan;42(1):e29-e34. doi: 10.1097/RLU.0000000000001435.

  PMID: 27819856 BACKGROUND

• Heinze B, Fuss CT, Mulatero P, Beuschlein F, Reincke M, Mustafa M, Schirbel A, Deutschbein T, Williams TA, Rhayem Y, Quinkler M, Rayes N, Monticone S, Wild V, Gomez-Sanchez CE, Reis AC, Petersenn S, Wester HJ, Kropf S, Fassnacht M, Lang K, Herrmann K, Buck AK, Bluemel C, Hahner S. Targeting CXCR4 (CXC Chemokine Receptor Type 4) for Molecular Imaging of Aldosterone-Producing Adenoma. Hypertension. 2018 Feb;71(2):317-325. doi: 10.1161/HYPERTENSIONAHA.117.09975. Epub 2017 Dec 26.

  PMID: 29279316 BACKGROUND

• Kempers MJ, Lenders JW, van Outheusden L, van der Wilt GJ, Schultze Kool LJ, Hermus AR, Deinum J. Systematic review: diagnostic procedures to differentiate unilateral from bilateral adrenal abnormality in primary aldosteronism. Ann Intern Med. 2009 Sep 1;151(5):329-37. doi: 10.7326/0003-4819-151-5-200909010-00007.

  PMID: 19721021 BACKGROUND

• Sam D, Kline GA, So B, Leung AA. Discordance Between Imaging and Adrenal Vein Sampling in Primary Aldosteronism Irrespective of Interpretation Criteria. J Clin Endocrinol Metab. 2019 Jun 1;104(6):1900-1906. doi: 10.1210/jc.2018-02089.

  PMID: 30590677 BACKGROUND

• Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

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• Buck AK, Haug A, Dreher N, Lambertini A, Higuchi T, Lapa C, Weich A, Pomper MG, Wester HJ, Zehndner A, Schirbel A, Samnick S, Hacker M, Pichler V, Hahner S, Fassnacht M, Einsele H, Serfling SE, Werner RA. Imaging of C-X-C Motif Chemokine Receptor 4 Expression in 690 Patients with Solid or Hematologic Neoplasms Using 68Ga-Pentixafor PET. J Nucl Med. 2022 Nov;63(11):1687-1692. doi: 10.2967/jnumed.121.263693. Epub 2022 Mar 3.

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Related Links

• Common Terminology Criteria for Adverse Events (CTCAE) \| Protocol Development \| CTEP \[Internet\]. \[cited 2022 May 17\].

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Fabien HYAFIL

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Touria AL AAMRI

CONTACT

0140271848; touria.el-aamri@aphp.fr

Liliane HAMMANI-BERKANI

CONTACT

0156093762; liliane.berkani@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 27, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (2)