Lymphedema Clinical Trial
Official title:
Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-NEB in Healthy Volunteers and Patients With Hepatic Space-occupying Lesions and Suspicious Lymph Nodes Metastasis
This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected infection. Changes of routine blood and urine tests and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be able to provide a written informed consent - Males and females, =18 years old; - Diagnostic CT or MRI suggesting a diagnosis of liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function. 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 because of cough, pain, etc. - Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. - Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance. |
Country | Name | City | State |
---|---|---|---|
China | PET centre | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | National Institute for Biomedical Imaging and Bioengineering (NIBIB) |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging | 1 years | ||
Secondary | Adverse events collection | Adverse events within 2 weeks after the injection and scanning of healthy volunteers and patients will be followed and assessed | 2 week | |
Secondary | Routine blood test | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | |
Secondary | Serum albumin | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | |
Secondary | Routine urine test | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | |
Secondary | Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Completed |
NCT06067880 -
Surgical Intervention and Lymphatic Diseases.
|
||
Active, not recruiting |
NCT04797390 -
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT02676752 -
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
|
||
Completed |
NCT02506530 -
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
|
N/A | |
Completed |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
Recruiting |
NCT01318785 -
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
|
Phase 2 | |
Enrolling by invitation |
NCT02375165 -
Biomarkers for the Detection of Lymphatic Insufficiency
|
||
Completed |
NCT02308488 -
Study of Prone Accelerated Breast And Nodal IMRT
|
N/A | |
Completed |
NCT01112189 -
Use of Stem Cells in Lymphedema Post Mastectomy
|
Phase 1/Phase 2 | |
Completed |
NCT00852930 -
Low Level Laser Treatment and Breast Cancer Related Lymphedema
|
Phase 4 | |
Completed |
NCT00743314 -
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
|
Early Phase 1 | |
Recruiting |
NCT06237907 -
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
|
||
Terminated |
NCT01580800 -
National Breast Cancer and Lymphedema Registry
|
||
Suspended |
NCT05366699 -
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
|
N/A | |
Completed |
NCT06249360 -
Lymphatic System Reflux After Lymphatic Operation
|
||
Completed |
NCT06220903 -
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
|
N/A | |
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |