Characterizing LAM With 11C-Choline PET/CT

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Early Phase 1

Conditions: Lymphangioleiomyomatosis

Treatments: Drug: 11C-Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT05087134

PUMCHLAM

Details and patient eligibility

About

It was reported that TSC2-deficient cells enhance phosphatidylcholine synthesis via the Kennedy pathway. 11C-Choline can reflect the metabolic process of choline in vivo by intravenous injection. The purpose of this study is the ability of 11C-Choline PET/CT to evaluate the baseline condition of LAM patients and the efficacy of rapamycin after treatment.

Full description

Tuberous Sclerosis Complex (TSC) is an autosomal dominant disorder caused by inactivating mutations of the TSC1 or TSC2 gene, characterized by neurocognitive impairment and benign tumors of the brain, skin, heart, and kidneys. Lymphangioleiomyomatosis (LAM) is a diffuse proliferation of α-smooth muscle actin-positive cells associated with cystic destruction of the lung. LAM occurs almost exclusively in women, as a TSC manifestation or a sporadic disorder (TSC1/TSC2 somatic mutations). Biomarkers of whole-body tumor burden/activity and response to rapalogs or other therapies remain needed in TSC/LAM. It was reported that TSC2-deficient cells enhance phosphatidylcholine synthesis via the Kennedy pathway. 11C-Choline can reflect the metabolic process of choline in vivo by intravenous injection. The purpose of this study is the ability of 11C-Choline PET/CT to evaluate the baseline condition of LAM patients and the efficacy of rapamycin after treatment.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• provide a written informed consent; Diagnostic CT or MRI suggesting a diagnosis of lymphangioleiomyomatosis.

Exclusion criteria

• Females planning to bear a child recently or with childbearing potential; Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

11C-Choline PET/CT for Lymphangioleiomyomatosis (LAM)

Experimental group

Description:

The patients were injected with 11C-Choline of 5-10mCi and underwent PET/CT scan 20\~40min after the injection.

Treatment:

Drug: 11C-Choline