Gallium-68 Labeled Pentixafor PET/CT in Adrenal Masses

Phase 2

• Conditions: Adrenal Mass
• Interventions: Diagnostic Test: Gallium-68 Pentixafor PET/CT

• Registration Number: NCT04859959
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The CXC chemokine receptor type 4 (CXCR4), which is a G protein-coupled receptor expressed on the surface of the cell membrane, contributes to the development and progression of malignancies and functional endocrine disorders. CXCR4 expression has been reported to be upregulated in aldosterone-producing adenomas and cortisol-producing adenomas; however, its expression is almost negligible in non-functioning adrenal adenomas. Besides, CXCR4 is also hardly expressed by the tumor cells in paragangliomas. 68Ga-pentixafor, a CXCR4-specific PET tracer, may therefore be effective for the evaluation of the functional lateralization of adrenal lesion and identification of functional adrenocortical adenomas. In this pilot study, we aimed to develop 68Ga-pentixafor PET/CT as a noninvasive test for the recognition of functional adrenocortical lesions and to help guide the management of patients with suspicious adrenal masses.

Detailed Description

Identifying the functional distinctions between adrenal nodules remains challenging. It is imperative to employ the least invasive approach for the functional evaluation of adrenal masses (e.g., adrenal venous sampling) without compromising efficacy. The conventional functional diagnosis protocol of adrenal masses is based on a combination of clinical symptoms, the presence of adrenal hormonal disorders, and radiographic features. However, the clinical manifestations of endocrine diseases are diverse, and a lack of uniformity in diagnostic protocols and assay methods for determining hormonal activation in adrenal disorders results in a significant variability in measurements. Besides, conventional imaging provides information of the morphology of a lesion, but not its functional status. Thus, an effective and non-invasive workup is needed for the characterization of adrenal masses and their therapeutic management.

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2020-07
• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Written informed consent.
• Patients with adrenal diseases.
• A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the adrenal region within the previous 6 months prior to dosing day is available

Exclusion Criteria

• Pregnant or breast-feeding women.
• Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
• Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-Pentixafor PET/CT scan	Gallium-68 Pentixafor PET/CT	Intravenous Inject 68Ga-Pentixafor and perform PET/CT scan 1h later.

Primary Outcome Measures

Name	Time	Method
The diagnosis efficiency	through study completion, an average of 2 year	The diagnosis efficiency of functional lateralization and identification of functional adrenocortical adenomas

Secondary Outcome Measures

Name	Time	Method
Standard uptake value (SUV)	From right after tracer injection to 2-hours post-injection	Determination of SUV for detected lesions and normal liver and adrenal tissue of 68Ga-Pentixafor

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Peking, China