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

June 24, 2024 updated by: Assistance Publique - Hôpitaux de Paris

"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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: [68Ga]Ga-PentixaFor; single injection
[68Ga]Ga-PentixaFor; 150 (± 50) MBq intravenous injection over 30 seconds; single injection
Combination product: [68Ga]Ga-PentixaFor PET imaging
PET imaging of adrenal glands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relevant biomarkers strongly associated with primary lateralized hyperaldosteronism
Time Frame: 30 days after inclusion
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aldosterone-to-cortisol ratio between the two adrenal veins on AVS
Time Frame: at inclusion
at inclusion
Lateralization index during AVS
Time Frame: at baseline (during AVS day)
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
Time Frame: 30 days after inclusion
30 days after inclusion
Proportion of patients with persistence of PA
Time Frame: 6 months after surgical adrenalectomy
Patient with a secretion of aldosterone assessed in blood test after surgical adrenalectomy,
6 months after surgical adrenalectomy
CXCR4 expression levels by immuno-histology highest CXCR4 density
Time Frame: 6 months after surgical adrenalectomy
highest CXCR4 density
6 months after surgical adrenalectomy
Adenoma size on CT
Time Frame: 30 days after inclusion
30 days after inclusion
Adenoma size on histology
Time Frame: 6 months after surgical adrenalectomy
6 months after surgical adrenalectomy
Incidence of Treatment Emergent Adverse Events after [68Ga]Ga-PentixaFor injection (tolerability)
Time Frame: 30 days after [68Ga]Ga-PentixaFor injection
  • 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.
30 days after [68Ga]Ga-PentixaFor injection
Incidence of Treatment Emergent Serious Adverse Events after [68Ga]Ga-PentixaFor injection (Safety)
Time Frame: 12 months after [68Ga]Ga-PentixaFor injection
- Serious adverse events (any cause).
12 months after [68Ga]Ga-PentixaFor injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Pentixapharm AG

Investigators

  • Principal Investigator: Fabien HYAFIL, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220881
  • 2023-505507-22-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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