Status:
COMPLETED
Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Uppsala University
Conditions:
Hodgkin Lymphoma, Adult
Non-Hodgkin Lymphoma, Adult
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin Lymphoma. The primary objective are: 1. To assess the distribution o...
Detailed Description
The overall goal is to study the effectiveness of SPECT imaging Hodgkin Lymphoma and Non Hodgkin Lymphoma Using technetium-99m labeled 1-thio-D-glucose. Phase I of the study: Biodistribution of 99mT...
Eligibility Criteria
Inclusion
- Subject is \> 18 years of age
- Clinical and radiological diagnosis of Hodgkin Lymphoma and Non Hodgkin Lymphoma with immunohistological verification.
- White blood cell count: \> 2.0 x 10\^9/L
- Haemoglobin: \> 80 g/L
- Platelets: \> 50.0 x 10\^9/L
- ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
- Bilirubin =\< 2.0 times Upper Limit of Normal
- Serum creatinine: Within Normal Limits
- Blood glucose level not more than 5.9 mmol/L
- A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
- Subject is capable to undergo the diagnostic investigations to be performed in the study
- Informed consent
Exclusion
- Active current autoimmune disease or history of autoimmune disease
- Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- Known HIV positive or chronically active hepatitis B or C
- Administration of other investigational medicinal product within 30 days of screening
- Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Key Trial Info
Start Date :
January 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04292626
Start Date
January 19 2020
End Date
March 19 2021
Last Update
April 1 2021
Active Locations (1)
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1
TomskNRMC
Tomsk, Russia