Gallium-68 Labeled Pentixafor PET/CT in Adrenal Masses

NCT04859959 | Unknown Phase 2

• 1 other identifier: PenAM
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Mass

Outcome Measures

Primary Outcomes (1)

• The diagnosis efficiency

  The diagnosis efficiency of functional lateralization and identification of functional adrenocortical adenomas

  through study completion, an average of 2 year

Secondary Outcomes (1)

• Standard uptake value (SUV)

  From right after tracer injection to 2-hours post-injection

Study Arms (1)

68Ga-Pentixafor PET/CT scan

EXPERIMENTAL

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

Diagnostic Test: Gallium-68 Pentixafor PET/CT

Interventions

Gallium-68 Pentixafor PET/CT DIAGNOSTIC_TEST

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.

68Ga-Pentixafor PET/CT scan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (1)

• Ding J, Li X, Liu S, Gao Y, Zheng G, Hacker M, Zhang Y, Tong A, Huo L. Clinical Value of 68Ga-Pentixafor PET/CT in Subtype Diagnosis of Primary Aldosteronism Patients with Adrenal Micronodules. J Nucl Med. 2024 Jan 2;65(1):117-124. doi: 10.2967/jnumed.123.266061.

  PMID: 38050127 DERIVED

Study Officials

• Li Huo, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Ding, MD

CONTACT

+86 17810259215; 707462902@qq.com

Li Huo, MD

CONTACT

+86 13910801986; huoli@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: July 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 26, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)