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Hodgkin Lymphoma, AdultPhase 1NCT04292626

Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose

A Phase 1 study testing SPECT with 99mTc-1-thio-D-glucose in people with Hodgkin Lymphoma, Adult and Non-Hodgkin Lymphoma, Adult, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals. 2. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SPECT with 99mTc-1-thio-D-glucose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteRussia
Study dates
19 Jan 2020to 19 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • TomskNRMC

    Tomsk

Other trials in Russia

About this study

Official title: SPECT Imaging of Lymphoma Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose)

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 of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals.
  2. To evaluate dosimetry of 99mTc-1-thio-D-glucose.
  3. To study the safety and tolerability of the drug 99mTc-1-thio-D-glucose after a single injection in a diagnostic dosage.

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.
Read the 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 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin Lymphoma.

The main objectives of the study:

  1. To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with Lymphoma at different time intervals.
  2. To evaluate dosimetry of 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters of the drug after a single intravenous administration.
  3. To study the safety of use and tolerability of the drug 99mTc-1-thio-D-glucose after a single intravenous administration in a diagnostic dosage.

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.

Being tested
SPECT with 99mTc-1-thio-D-glucose
Keywords
Hodgkin Lymphoma, Non Hodgkin Lymphoma, 99mTc-1-thio-D-glucose, SPECT
Medical subject headings
Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPECT with 99mTc-1-thio-D-glucoseDiagnostic 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.

Study groups in NCT04292626
Study groupRoleWhat they receive
LymphomaExperimentalAt least five (5) evaluable subjects with Hodgkin Lymphoma or Non Hodgkin Lymphoma. The tested injected dose of 500 MBq.
Receives: Diagnostic Test: SPECT with 99mTc-1-thio-D-glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

  2. 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

    Measured: 6 hours

  3. 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

    Measured: 6 hours

  4. 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)

    Measured: 6 hours

Secondary outcomes (4)

  1. 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)

    Measured: 24 hours

  2. Safety attributable to 99mTc-1-thio-D-glucose injections (laboratory tests)

    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)

    Measured: 24 hours

  3. 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)

    Measured: 24 hours

  4. 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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start19 Jan 2020
  3. Primary completion19 Feb 2021
  4. Study completion19 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292626
Sponsor's protocol ID
ORI-07/2
Status last verified
Jun 2026
First submitted
20 Feb 2020
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPECT with 99mTc-1-thio-D-glucose in people with Hodgkin Lymphoma, Adult and Non-Hodgkin Lymphoma, Adult, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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