Gallium-68 Labeled Pentixafor PET/CT in Adrenal Masses

Gallium-68 Labeled Pentixafor PET/CT in the Diagnosis and Characterization of Adrenal Masses

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.

Study Overview

• Status: Unknown
• Conditions: Adrenal Mass
• Intervention / Treatment: Diagnostic test: Gallium-68 Pentixafor PET/CT

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Peking, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Shuyang Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-Pentixafor PET/CT scan; Intravenous Inject 68Ga-Pentixafor and perform PET/CT scan 1h later.	Diagnostic test: Gallium-68 Pentixafor PET/CT; Intravenous injection of one dosage of 74-222 MBq (2-6 mCi) Gallium-68 Pentixafor. Tracer doses of Gallium-68 Pentixafor will be used to image adrenal lesions by PET/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnosis efficiency	The diagnosis efficiency of functional lateralization and identification of functional adrenocortical adenomas	through study completion, an average of 2 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Li Huo, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PenAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No