Reduction of aortic inflammation in patients with cancer by Trehalose therapeutic effect
Design
This study has been designed as a case study
Settings and conduct
Razavi hospital
Participants/Inclusion and exclusion criteria
Entry conditions for trial: Patients with TBR higher than 1.6
Exit criteria for trial : Diabetic patients with HbA1C higher than 6.5
Patients who receive anti inflammatory medicine such as statins and aspirin
Patients who diagnosed with vasculitis or bacterial infection
Intervention groups
Trehalose 15 gr/ml
Main outcome variables
The investigation of improvement in aortic vascular inflammation by using Pet scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130829014521N20
Registration date:2022-06-07, 1401/03/17
Registration timing:prospective
Last update:2022-06-07, 1401/03/17
Update count:0
Registration date
2022-06-07, 1401/03/17
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-07-22, 1401/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the therapeutic effects of Trehalose in aortic inflammation in patients with cancer
Public title
Trehalose and aortic inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients with aortic inflammation with a cutoff of 1.6 or more for the TBR in the first scan
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
2
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Two cancer patients with aortic inflammation and TBR above 1.6 in the first scan will be enrolled in this study. Patients will receive a single dose of intravenous injection of trehalose (15 g / 100 ml) and will be re-scanned a week later to assess the therapeutic effects of trehalose on aortic inflammation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences (Ethics Committee)
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.MUMS.REC.1401.026
Health conditions studied
1
Description of health condition studied
Aortic inflammation in patients with cancer
ICD-10 code
I77.6
ICD-10 code description
Arteritis, unspecified
Primary outcomes
1
Description
Investigation of aortic inflammation with (18F-FDG PET) scan
Timepoint
one week after administration of trehalose
Method of measurement
(18F-FDG PET) scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one dose of Trehalose by intravenous injection (15 gr/ml)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razavi hospital of Mashhad
Full name of responsible person
Farshad Emami
Street address
Kalantari highway, Mashhad, Khorasan razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
30007273010022
Phone
+98 51 3666 8888
Email
farshademami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice-Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
َAmirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Amirhossein Sahebkar
Position
Associate proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, East door of Ferdowsi University, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shabnam radbakhsh
Position
P.h.D Student
Latest degree
Ph.D.
Other areas of specialty/work
Medical biotechnology
Street address
Bahonar blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3882 3258
Email
Radbakhshs971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD