Adrenal Mass Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
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China | Peking Union Medical College Hospital | Peking |
Lead Sponsor | Collaborator |
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Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnosis efficiency | The diagnosis efficiency of functional lateralization and identification of functional adrenocortical adenomas | through study completion, an average of 2 year | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
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