Characterizing LAM With 11C-Choline PET/CT

Lymphangioleiomyomatosis Clinical Trial

Official title:

Characterizing Lymphangioleiomyomatosis (LAM) With 11C-Choline PET/CT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05087134
• Other study ID #: PUMCHLAM
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 2021
• Est. completion date: September 2023

Study information

• Verified date: September 2021
• Source: Peking Union Medical College Hospital
• Contact: Guozhu Hou, MD
• Phone: 15611145656
• Email: 15611145656[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphangioleiomyomatosis

Intervention

Drug:
• 11C-Choline
11C-Choline were injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Dongcheng

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 11C-Choline in LAM lesions	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lymphatic lesion will be measured.	through study completion, an average of 2 year