Clincosm LogoSign in Get a demo

CXCR4 Targeted PET Imaging in APA Preoperative Localization Diagnosis

Sponsor
Zhongnan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05839483
Collaborator
(none)
50
Enrollment
1
Arm
19.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of CXCR4 targeted PET imaging in preoperative localization diagnosis of primary aldosteronism (PA). Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET, and then underwent adrenal venous sampling (AVS). Then, the responsible adrenal adenoma will be resected by adrenalectomy, and examined with pathological section and staining. Researchers will compare the sensitivity and specificity between 68Ga-PentixaFor PET imaging and AVS in preoperative localization diagnosis of PA.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CXCR4
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Single Center Study on the Evaluation of Diagnostic Efficacy of CXCR4 Targeted PET Imaging in Primary Aldosteronism
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CXCR4

scanned by 68Ga-PentixaFor PET imaging

Diagnostic Test: CXCR4
Participants diagnosed with PA will be asked to be scanned by 68Ga-PentixaFor PET imaging.

Outcome Measures

Primary Outcome Measures

  1. renin [immediately after admission]

    measure the level of renin in blood

  2. aldosterone [immediately after admission]

    measure the level of aldosterone in blood

  3. SUVmax [immediately after 68Ga-PentixaFor PET imaging]

    measure the maximum standardized uptake value of adrenal adenoma, liver, and lateral normal adrenal

  4. sensitivity [immediately after pathological examination]

    the sensitivity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

  5. specificity [immediately after pathological examination]

    the specificity of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

  6. positive predictive value,PPV [immediately after pathological examination]

    the PPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

  7. negative predictive value, NPV [immediately after pathological examination]

    the NPV of 68Ga-PentixaFor PET imaging in preoperative localization diagnosis of PA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients with PA, confirmed by an elevated aldosterone/renin ratio (ARR) and an intravenous salt loading test.

  • The patient has provided written informed consent authorisation before participating in the study.

  • The patient is 18 to 70 years of age at the time of consent.

Exclusion Criteria:

  • Refusal by the patients to undergo 68Ga-PentixaFor PET/CT, AVS, CT, or adrenalectomy.

  • Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3).

  • Suspicion of adrenocortical carcinoma.

  • Severe comorbidity potentially interfering with treatment or health-related quality of life.

  • Patients need to take drugs that interfere with clinical research.

  • Any medical condition present that in the opinion of the investigator will affect patients clinical status.

  • Pregnancy or lactation.

  • Estimated glomerular filtration rate <40mL/min/1.73m2.

  • Interfering treatment in between 68Ga-PentixaFor PET/CT and AVS.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhongnan Hospital

Investigators

  • Principal Investigator: Zhe Meng, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongnan Hospital
ClinicalTrials.gov Identifier:
NCT05839483
Other Study ID Numbers:
  • Zhe Meng
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhongnan Hospital
Hypertension
Hypokalemia
Adrenal adenoma
Additional relevant MeSH terms:
Adenoma

Study Results

No Results Posted as of May 3, 2023