NCT04292626

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

April 1, 2021

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 20, 2020

Last Update Submit

March 30, 2021

Conditions

Hodgkin Lymphoma, AdultNon-Hodgkin Lymphoma, Adult

Keywords

Hodgkin LymphomaNon Hodgkin Lymphoma99mTc-1-thio-D-glucoseSPECT

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (4)

  • Safety attributable to 99mTc-1-thio-D-glucose injections (physical findings)

    24 hours

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

    24 hours

  • Safety attributable to 99mTc-1-thio-D-glucose injections (incidence and severity of adverse events)

    24 hours

  • Safety attributable to 99mTc-1-thio-D-glucose injections

    24 hours

Study Arms (1)

Lymphoma

EXPERIMENTAL

At least five (5) evaluable subjects with Hodgkin Lymphoma or Non Hodgkin Lymphoma. The tested injected dose of 500 MBq.

Diagnostic Test: SPECT with 99mTc-1-thio-D-glucose

Interventions

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.

Lymphoma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-Hodgkin

Interventions

Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Vladimir I Chernov, MD, PhD

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 3, 2020

Study Start

January 19, 2020

Primary Completion

February 19, 2021

Study Completion

March 19, 2021

Last Updated

April 1, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
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.
Access Criteria
Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU(1)