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Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion

17. mai 2026 oppdatert av: Peking University First Hospital

The goal of this observational study is to evaluate the diagnostic accuracy of 68 68

Ga-Pentixafor-CXCR4 PET/CT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for unilateral adrenalectomy or ablation. The main questions it aims to answer are:

What is the overall diagnostic performance of 68 68 Ga-Pentixafor-CXCR4 PET/CT for lateralizing the dominant source of aldosterone and cortisol co-secretion, as measured by the area under the receiver operating characteristic curve (AUC)?

How do the PET/CT-based lateralization results compare with adrenal venous sampling (AVS) and metanephrine-corrected AVS, and are there clinical or biochemical factors that predict discordance between these methods?

Researchers will compare the dominant side determined by PET/CT with the reference standard derived from postoperative PASO outcomes and cortisol-related hormonal outcomes (supplemented by histopathology) to assess sensitivity, specificity, accuracy, and agreement. They will further compare PET/CT results to conventional AVS and metanephrine-corrected AVS to determine concordance and identify potential predictors of discordant cases.

Participants will:

Provide written informed consent and undergo baseline clinical, biochemical, and imaging assessments as part of routine PA+MACS work-up.

Undergo a single 68 68 Ga-Pentixafor-CXCR4 PET/CT scan, along with AVS and metanephrine-corrected AVS, typically within a 4-week window.

Be discussed by a multidisciplinary team that integrates all diagnostic information to formulate an individualized surgical plan.

If surgery proceeds, be followed at 1, 3, 6, and 12 months postoperatively to assess blood pressure, antihypertensive medication use, serum potassium, aldosterone/renin/cortisol levels, and 1-mg overnight dexamethasone suppression test results.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

130

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Peking University First Hospital, Beijing
        • Ta kontakt med:
          • Peking University First Hospital Peking University First Hospital
          • Telefonnummer: 01083572418
          • E-post: 2300736651@qq.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of adult patients aged 18-80 years with a confirmed diagnosis of primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS), who are scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging and meet clinical indications for unilateral adrenalectomy or adrenal ablation. Participants are recruited consecutively from outpatient and inpatient settings at Peking University First Hospital, including both prospectively enrolled patients and retrospectively identified patients with previously confirmed PA+MACS and available clinical data. All participants must provide written informed consent and be willing to complete at least 12 months of postoperative follow-up.

Beskrivelse

Inclusion Criteria:

  • Age 18-80 years.

Confirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol >1.8 µg/dL (>50 nmol/L) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST).

Scheduled to undergo [⁶⁸Ga]Pentixafor-CXCR4 PET/CT imaging.

Meeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months.

Exclusion Criteria:

  • Previous adrenal surgery or confirmed adrenal malignancy.

Pregnancy or lactation.

Severe renal impairment (eGFR <30 mL·min-¹·1.73 m-²) or contraindication to contrast agents/radiopharmaceuticals.

Inability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection/unstable comorbidities that preclude relevant examinations.

Definite overt Cushing's syndrome (CS).

Critical missing data, inability to complete the required examinations, or anticipated inability to attend follow-up.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
area under the receiver operating characteristic curve (AUC) for 68Ga-Pentixafor-CXCR4 PET/CT in determining the dominant side of adrenal hormone excess in patients with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS）
Tidsramme: From enrollment to 12 months postoperatively
From enrollment to 12 months postoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University First Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2025

Primær fullføring (Antatt)

31. mai 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SFMSSXPETCT

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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