Characterizing LAM With 11C-Choline PET/CT
Characterizing Lymphangioleiomyomatosis (LAM) With 11C-Choline PET/CT
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 21, 2021
September 1, 2021
10 months
September 14, 2021
October 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
11C-Choline PET/CT for Lymphangioleiomyomatosis (LAM)
EXPERIMENTALThe patients were injected with 11C-Choline of 5-10mCi and underwent PET/CT scan 20\~40min after the injection.
Interventions
11C-Choline were injected into the patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- \- provide a written informed consent; Diagnostic CT or MRI suggesting a diagnosis of lymphangioleiomyomatosis.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking union medical college hospital
Beijing, Dongcheng, 100010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fang Li, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
October 21, 2021
Study Start
November 1, 2021
Primary Completion
September 1, 2022
Study Completion
September 1, 2023
Last Updated
October 21, 2021
Record last verified: 2021-09