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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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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:
The secondary objective are:
1. To compare the obtained 99mTc-1-thio-D-glucose SPECT imaging results with the data of CT imaging and/or 18F-FDG positron emission tomography (PET) and immunohistochemical (IHC) studies in Lymphoma patients.
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 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin Lymphoma.
The main objectives of the study:
Additional research tasks:
1. To conduct a comparative analysis of the diagnostic information obtained in the visualization of Lymphoma by SPECT using 99mTc-1-thio-D-glucose with data obtained by CT and/or positron emission tomography (PET) and immunohistochemical (IHC) research of postoperative material.
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphoma | Experimental | At least five (5) evaluable subjects with Hodgkin Lymphoma or Non Hodgkin Lymphoma. The tested injected dose of 500 MBq. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT with 99mTc-1-thio-D-glucose | Diagnostic Test | One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent) | Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical | 24 hours |
| SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts) | 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts | 6 hours |
| SPECT-based 99mTc-1-thio-D-glucose uptake value (counts) | Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts | 6 hours |
| Tumor-to-background ratio (SPECT) | The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety attributable to 99mTc-1-thio-D-glucose injections (physical findings) | The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline) | 24 hours |
| Safety attributable to 99mTc-1-thio-D-glucose injections (laboratory tests) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir I Chernov, MD, PhD | Tomsk NRMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TomskNRMC | Tomsk | Russia |
Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline) |
| 24 hours |
| Safety attributable to 99mTc-1-thio-D-glucose injections (incidence and severity of adverse events) | The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent) | 24 hours |
| Safety attributable to 99mTc-1-thio-D-glucose injections | Percent of participants with treatment-related adverse events requiring drug treatment will be used to assess the safety attributable to 99mTc-1-thio-D-glucose injections. | 24 hours |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |