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Characterizing LAM With 11C-Choline PET/CT

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ClinicalTrials.gov Identifier: NCT05087134
Recruitment Status : Not yet recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphangioleiomyomatosis Drug: 11C-Choline Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterizing Lymphangioleiomyomatosis (LAM) With 11C-Choline PET/CT
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: 11C-Choline PET/CT for Lymphangioleiomyomatosis (LAM)
The patients were injected with 11C-Choline of 5-10mCi and underwent PET/CT scan 20~40min after the injection.
Drug: 11C-Choline
11C-Choline were injected into the patients before the PET/CT scans




Primary Outcome Measures :
  1. Standardized uptake value of 11C-Choline in LAM lesions [ Time Frame: through study completion, an average of 2 year ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087134


Contacts
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Contact: Guozhu Hou, MD 15611145656 15611145656@163.com
Contact: Fang Li, MD 13901054627 lifang@pumch.cn

Locations
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China, Dongcheng
Peking union medical college hospital
Beijing, Dongcheng, China, 100010
Contact: Guozhu Hou, MD    15611145656    15611145656@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Fang Li, MD Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05087134    
Other Study ID Numbers: PUMCHLAM
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphangioleiomyomatosis
Lymphangiomyoma
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Neoplasms
Perivascular Epithelioid Cell Neoplasms
Neoplasms, Connective and Soft Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents