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Characterizing LAM With 11C-Choline PET/CT

NCT ID: NCT05087134

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphangioleiomyomatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

11C-Choline

Intervention Type DRUG

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

Interventions

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11C-Choline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking union medical college hospital

Beijing, Dongcheng, China

Site Status

Countries

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China

Central Contacts

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Guozhu Hou, MD

Role: CONTACT

[email protected]
15611145656

Fang Li, MD

Role: CONTACT

[email protected]
13901054627

Facility Contacts

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Guozhu Hou, MD

Role: primary

[email protected]
15611145656

Other Identifiers

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PUMCHLAM

Identifier Type: -

Identifier Source: org_study_id