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Primary AldosteronismPhase 2PENTALONNCT06478875

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

A Phase 2 study testing [68Ga]Ga-PentixaFor PET imaging in people with Primary Aldosteronism, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Primary Aldosteronism
What is being tested?
[68Ga]Ga-PentixaFor PET imaging
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesFrance
Study dates
Jun 2024to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Touria AL AAMRI contact

0140271848

touria.el-aamri@aphp.fr

Liliane HAMMANI-BERKANI contact

0156093762

liliane.berkani@aphp.fr

France2 sites

  • hôpital Cochin

    Paris, 75014

    Anne-Ségolène Cottereau, annesegolene.cottereau@aphp.fr

    Yvan Mouraeff, yvan.mouraeff@aphp.fr

  • Hôpital européen Georges Pompidou - APHP

    Paris, 75015

    Laurence Amar, laurence.amar@aphp.fr

    Julien RIANCHO, julien.riancho@aphp.fr

Other trials in France

About this study

Official title: "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"

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).

Read the detailed description

The identification of the cause of primary aldosteronism (PA) is critical because, in case of lateralized secretion of aldosterone, a surgical treatment can be offered to patients with the objective of full patient recovery, whereas in case of bilateral secretion, only a long-term medical treatment with mineralocorticoid receptor antagonists should be considered. The presence or absence of adrenal nodule on morphological imaging does not allow us to state on the lateralization or not of aldosterone secretion. Moreover, on one hand, the prevalence of adrenal incidentalomas, mostly non-secreting, can be detected in between 2 to 10% of general population. On the other hand, unilateral secretion of aldosterone exists in 30% of patients with normal adrenal glands on imaging. The AVS with measurements of the concentrations of aldosterone is the closest to a referral exam to confirm the diagnosis of lateralized secretion of aldosterone, but it is a complex and invasive procedure with only limited access to centers with expertise in invasive radiology and an important heterogeneity in interpretation. The development of noninvasive imaging approaches allowing for a more specific identification of lateralized vs. bilateral aldosterone secretion would, hence, have a major impact on the clinical management of these patients.

Being tested
[68Ga]Ga-PentixaFor PET imaging
Keywords
[68Ga]Ga-PentixaFor positron emission tomography, adrenal vein sampling, unilateral adrenal secretion
Medical subject headings
Hyperaldosteronism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-PentixaFor PET imagingCombination product

    PET imaging of adrenal glands

Study groups in NCT06478875
Study groupRoleWhat they receive
[68Ga]Ga-PentixaFor; single injectionOther[68Ga]Ga-PentixaFor; 150 (± 50) MBq intravenous injection over 30 seconds; single injection
Receives: Combination Product: [68Ga]Ga-PentixaFor PET imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days after inclusion

Secondary outcomes (9)

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

    Measured: at inclusion

  2. Lateralization index during AVS

    Measured: at baseline (during AVS day)

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

    Measured: 30 days after inclusion

  4. Proportion of patients with persistence of PA

    Patient with a secretion of aldosterone assessed in blood test after surgical adrenalectomy,

    Measured: 6 months after surgical adrenalectomy

  5. CXCR4 expression levels by immuno-histology highest CXCR4 density

    highest CXCR4 density

    Measured: 6 months after surgical adrenalectomy

  6. Adenoma size on CT

    Measured: 30 days after inclusion

  7. Adenoma size on histology

    Measured: 6 months after surgical adrenalectomy

  8. Incidence of Treatment Emergent Adverse Events after [68Ga]Ga-PentixaFor injection (tolerability)

    • Adverse events deemed "medically significant" defined by Allergic and anaphylactic reaction ≥ grade 3 according to CTCAE during or following the injection of the radiopharmaceutical
    • Adverse events of special interest defined by Cutaneous eruption in the three weeks following the injection.

    Measured: 30 days after [68Ga]Ga-PentixaFor injection

  9. Incidence of Treatment Emergent Serious Adverse Events after [68Ga]Ga-PentixaFor injection (Safety)

    • Serious adverse events (any cause).

    Measured: 12 months after [68Ga]Ga-PentixaFor injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06478875
Sponsor's protocol ID
APHP220881
Other IDs
2023-505507-22-00, 2023
Acronym
PENTALON
Status last verified
May 2024
First submitted
17 May 2024
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Publications

  • Mulatero P, Monticone S, Deinum J, Amar L, Prejbisz A, Zennaro MC, Beuschlein F, Rossi GP, Nishikawa T, Morganti A, Seccia TM, Lin YH, Fallo F, Widimsky J. Genetics, prevalence, screening and confirmation of primary aldosteronism: a position statement and consensus of the Working Group on Endocrine Hypertension of The European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1919-1928. doi: 10.1097/HJH.0000000000002510.

    PubMed 32890264

  • 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.

    PubMed 27315757

  • Mulatero P, Sechi LA, Williams TA, Lenders JWM, Reincke M, Satoh F, Januszewicz A, Naruse M, Doumas M, Veglio F, Wu VC, Widimsky J. Subtype diagnosis, treatment, complications and outcomes of primary aldosteronism and future direction of research: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1929-1936. doi: 10.1097/HJH.0000000000002520.

    PubMed 32890265

  • Hyafil F, Pelisek J, Laitinen I, Schottelius M, Mohring M, Doring Y, van der Vorst EP, Kallmayer M, Steiger K, Poschenrieder A, Notni J, Fischer J, Baumgartner C, Rischpler C, Nekolla SG, Weber C, Eckstein HH, Wester HJ, Schwaiger M. Imaging the Cytokine Receptor CXCR4 in Atherosclerotic Plaques with the Radiotracer 68Ga-Pentixafor for PET. J Nucl Med. 2017 Mar;58(3):499-506. doi: 10.2967/jnumed.116.179663. Epub 2016 Oct 27.

    PubMed 27789718

  • 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.

    PubMed 27819856

  • 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.

    PubMed 29279316

  • 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.

    PubMed 19721021

  • 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.

    PubMed 30590677

  • 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.

    PubMed 26934393

  • 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.

    PubMed 35241482

  • Herrmann K, Lapa C, Wester HJ, Schottelius M, Schiepers C, Eberlein U, Bluemel C, Keller U, Knop S, Kropf S, Schirbel A, Buck AK, Lassmann M. Biodistribution and radiation dosimetry for the chemokine receptor CXCR4-targeting probe 68Ga-pentixafor. J Nucl Med. 2015 Mar;56(3):410-6. doi: 10.2967/jnumed.114.151647. Epub 2015 Feb 19.

    PubMed 25698782

  • Brenner DJ, Doll R, Goodhead DT, Hall EJ, Land CE, Little JB, Lubin JH, Preston DL, Preston RJ, Puskin JS, Ron E, Sachs RK, Samet JM, Setlow RB, Zaider M. Cancer risks attributable to low doses of ionizing radiation: assessing what we really know. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):13761-6. doi: 10.1073/pnas.2235592100. Epub 2003 Nov 10.

    PubMed 14610281

  • Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

    PubMed 28576687

  • Rossi GP, Barisa M, Allolio B, Auchus RJ, Amar L, Cohen D, Degenhart C, Deinum J, Fischer E, Gordon R, Kickuth R, Kline G, Lacroix A, Magill S, Miotto D, Naruse M, Nishikawa T, Omura M, Pimenta E, Plouin PF, Quinkler M, Reincke M, Rossi E, Rump LC, Satoh F, Schultze Kool L, Seccia TM, Stowasser M, Tanabe A, Trerotola S, Vonend O, Widimsky J Jr, Wu KD, Wu VC, Pessina AC. The Adrenal Vein Sampling International Study (AVIS) for identifying the major subtypes of primary aldosteronism. J Clin Endocrinol Metab. 2012 May;97(5):1606-14. doi: 10.1210/jc.2011-2830. Epub 2012 Mar 7.

    PubMed 22399502

  • Assalia A, Gagner M. Laparoscopic adrenalectomy. Br J Surg. 2004 Oct;91(10):1259-74. doi: 10.1002/bjs.4738.

    PubMed 15376201

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [68Ga]Ga-PentixaFor PET imaging in people with Primary Aldosteronism, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Touria AL AAMRI (0140271848, touria.el-aamri@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

relevant biomarkers strongly associated with primary lateralized hyperaldosteronism (time frame: 30 days after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06478875, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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