Clinical use of 99mTc-CXCR4 radiopharmaceutical in glioblastoma patients
Design
In this study, 15 patients with primary diagnosis of glioma based on clinical criteria and radiological imaging, who referred to Namazi or Chamran hospital for surgery and have the conditions to enter the study, were selected and before surgery, they were referred to the nuclear medicine department of Namazi hospital.
Settings and conduct
Patients who meet the conditions for entering the study are sent to the nuclear medicine department of Shiraz Namazi Hospital. Intravenous injection of radiopharmaceutical is done for each patient and after 3 hours of injection, imaging is done. The pathology results of the patients after surgery are compared with the scan results.
Participants/Inclusion and exclusion criteria
Patients with primary diagnosis of glioma based on clinical criteria and radiological imaging. The criteria for entering the study include the following patients: glioma has been diagnosed based on MRI within the last month; the patient is a candidate for surgical resection and has not undergone any type of anti-cancer treatment; the patient's condition is stable to perform the scan, the patient is ready to perform the scan have consent and are not pregnant or breastfeeding at the time of the scan.
Exclusion criteria include patients with multiple masses; patients who need emergency interventions after initial diagnosis; patients whose tumor cannot be operated and patients who do not consent to scan or surgery.
Intervention groups
In this study, a group of patients was used to evaluate the applicability of 99mTc-CXCR4 radiopharmaceutical in the diagnosis of glioblastoma.
Main outcome variables
The average absorption of radiopharmaceuticals in glioblastoma; the sensitivity of 99mTc-CXCR4 scanning; the specificity of 99mTc-CXCR4 scanning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230703058654N1
Registration date:2023-10-22, 1402/07/30
Registration timing:prospective
Last update:2023-10-22, 1402/07/30
Update count:0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
tahereh firuzyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5387
Email address
firuzyar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating diagnostic value of 99mTc-CXCR4 scan in differentiation of high-grade and low-grade glioma
Public title
Evaluating diagnostic value of 99mTc-CXCR4 scan in glioblastoma
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has been diagnosed with glioma based on MRI within the last month
The patient is a candidate for surgical resection and has not undergone any type of anti-cancer treatment
The patient's condition is stable for the scan
The patient consents to the scan, and at the time of the scan
Do not be pregnant or breastfeeding
Exclusion criteria:
Patients with multiple masses
Patients who need emergency interventions after initial diagnosis
Patients whose tumor cannot be operated
Patients who do not consent to scan or surgery
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Expert Committee on Ethics in Biomedical Research, Faculty of Medicine, Shiraz University of Medical
Street address
Vice-Chancellor of the Medical School, 3rd Floor, Building No. 3, School of Medicine, Imam Hossein square, Zand St.
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.SUMS.MED.REC.1402.238
Health conditions studied
1
Description of health condition studied
Glioblastoma
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain, unspecified
Primary outcomes
1
Description
The mean amount of radioactivity uptake in low-grade glioma patients
Timepoint
3 hours after radiopharmaceutical administration
Method of measurement
SPECT/CT imaging
2
Description
The mean amount of radioactivity uptake in high-grade glioma patients
Timepoint
3 hours after radiopharmaceutical administration
Method of measurement
SPECT/CT imaging
3
Description
Sensitivity of imaging to detect high-grade glioma
Timepoint
3 hours after radiopharmaceutical administration
Method of measurement
SPECT/CT imaging and comparison with pathology results
4
Description
Sensitivity of imaging to detect low-grade glioma
Timepoint
3 hours after radiopharmaceutical administration
Method of measurement
SPECT/CT imaging and comparison with pathology results
Secondary outcomes
empty
Intervention groups
1
Description
The intervention groups include glioblastoma patients whose mass has been proven by imaging methods such as MRI. This evaluation is a diagnostic method using the single photon emission computed tomography (SPECT) modality, in which the radiopharmaceutical 99mTCc-CXCR4 is injected into patients at a dose of 20 millicuries. The CXCR4 peptide is produced as a kit by the Atomic Energy Organization and all chemical and bacterial purity tests are checked on it. The desired radiopharmaceutical is labeled in Namazi Hospital, Shiraz, and its radiochemical purity is checked and confirmed before injection to the patient. This radiopharmaceutical is injected intravenously to patients once. The place of injection is the nuclear medicine department of Shiraz Namazi Hospital, where there are necessary medical equipment and also a doctor for prevention and treatment in case the patient has complications caused by the injection. The results of the imaging are finally compared with the pathology results after surgery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr. Tahereh Firuzyar
Street address
Namazi hospital, Namazi Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5387
Email
firuzyar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad hashem Hashempour
Street address
7th floor, central building of Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Nuclear Science and Technology Research Institute
Full name of responsible person
Dr. Mostafa Erfani
Street address
Nuclear Science and Technology Research Institute, North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955933
Phone
+98 21 8822 1103
Email
mgandomkar@aeoi.org.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nuclear Science and Technology Research Institute
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. tahereh firuzyar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
radiopharmacy
Street address
Namazi hospital, Namazi Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5387
Email
firuzyar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Tahereh Ghaedian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Namazi hospital, Namazi Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5315
Email
tghaedian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. tahereh firuzyar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
radiopharmacy
Street address
Namazi hospital, Namazi Square, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5387
Email
firuzyar@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available