NCT04288518

Brief Summary

The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and recurrence of brain tumors. 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 Feb 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

February 15, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

February 19, 2020

Last Update Submit

October 18, 2023

Conditions

BrainNeoplasms

Keywords

99mTc-1-thio-D-glucoseBrainNeoplasmsSPECT

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 (unitless value)

    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, based on the rate of abnormal physical findings (percent)

    24 hours

  • Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent)

    24 hours

  • Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent)

    24 hours

  • Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent)

    24 hours

Study Arms (3)

Primary Brain Tumor

EXPERIMENTAL

The tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq). At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq.

Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose

Recurrence of Brain Tumor

EXPERIMENTAL

The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq

Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose

Benign intracranial lesions

EXPERIMENTAL

The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq. At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq

Drug: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose

Interventions

SPECT or SPECT-CT with 99mTc-1-thio-D-glucoseDRUG

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.

Also known as: 99mTc-1-thio-D-glucose
Benign intracranial lesionsPrimary Brain TumorRecurrence of Brain Tumor

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 a primary brain tumor or recurrence of a brain tumor with immunohistological verification.
  • Clinical and radiological diagnosis of a benign intracranial lesions.
  • White blood cell count: \> 2.0 x 10\^9/L
  • Haemoglobin: \> 80 g/L
  • Platelets: \> 50.0 x 10\^9/L
  • alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (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:

  • Second, non-brain malignancy
  • 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

Neoplasms

Study Officials

  • Vladimr I Chernov

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 28, 2020

Study Start

February 15, 2020

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

October 23, 2023

Record last verified: 2023-10

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)