Evaluation of the efficacy and safety of multiple Lu177-dotatate doses in recurrent meningioma
Design
َA single-arm phase 2 pilot study on 10 cases without control group to evaluate the efficacy and safety of multiple doses of Lu177-dotatate
Settings and conduct
Location: the nuclear medicine department of Namazi hospital in Shiraz.
Patient population: Patients with recurrent meningioma referred by neurosurgeon.
There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Recurrent meningioma or persistent tumoral tissue after at least 2 surgeries and with no response to other therapeutic measures; Sufficient Tc99m-octreotide uptake; consent to participate in the study; acceptable hematologic and renal function lab data; more than 6 months life expectancy.
Exclusion criteria: Pregnancy; Lactation; Being candidate for therapy with other methods; Uunpredictable complications; Severe hematologic or renal complications.
Intervention groups
The patients will receive at least 3 doses of 200 mCi Lu177-dotatate with at least 6 weeks interval.
For each cycle, Lu177-dotatate will be infused with aminoacid infusion according to the standard protocols and other prophylactic medication for prevention of limited complications will be administered. Then the patients will be asked to come back after 24 hours for post-therapy SPECT imaging.
Four to five weeks after each cycle lab data will be checked and the patient will be visited to decide about the next cycle.
Main outcome variables
Response to therapy based on MRI and Tc99m-octreotide scan findings; Hematologic and renal complications based on the results of blood tests.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190623043986N1
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Tahereh Ghaedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5315
Email address
tghaedian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of Lu177-dotatate in the treatment of recurrent meningioma
Public title
Effect of Lu177-dotatate in meningioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathologically-proved case of meningioma
Radiologic evidence of recurrence after at least two surgeries with no response to other standard therapies
Sufficient radiotracer uptake in the Tc99m-octreotide scan
Hemoglobulin (HB)>8 g/dl
White blood cell count (WBC) > 2500 /mm3
platelet count>70000 /mm3
Glomerular filtration rate (GFR) > 50ml/min
Consent to participate in the study
Life expectancy more than 6 months
Exclusion criteria:
Pregnancy or lactation
Being candidate for other therapeutic measures
Development of unpredictable complications or other limiting or severe diseases
Severe hematologic complications
Severe renal complications
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Namazi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.SUMS.MED.REC.1402.564
Health conditions studied
1
Description of health condition studied
Meningioma
ICD-10 code
C70.9
ICD-10 code description
Malignant neoplasm of meninges, unspecified
Primary outcomes
1
Description
Change in tumor size based on MRI findings
Timepoint
Before and during 3-6 months after therapy
Method of measurement
Brain MRI
2
Description
Change in radiotracer tumoral uptake based on Tc99m-octreotide scan
Timepoint
Before and during 3-6 months after therapy
Method of measurement
Tc99m-ocreotide scan
3
Description
Hematologic toxicity
Timepoint
4-5 weeks after each cycle
Method of measurement
Complete blood count (CBC)
4
Description
Renal toxicity
Timepoint
4-5 weeks after each cycle
Method of measurement
Measurement of creatinine by laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients will receive at least 3 doses of 200 mCi Lu177-dotatate with at least 6 weeks interval. For each cycle, before Lu177-dotatate infusion, anti-emetic and dexamethasone will be administered to prevent nausea/vomiting and surrounding brain tumor edema. Then aminoacid solution containing 25 mg lysin and 25mg arginine in 2litres of normal saline will be started for 4 hours. Thirty minutes after start of aminoacid infusion, 200 mCi Lu177-dotatate manufactured by Parsisotope company, will be slowly infused during 30 minutes from a separate IV line. Vital sign monitoring will be performed during infusion. Then the patients will be asked to come back after 24hours for post-therapy SPECT imaging. Lab data will be checked 4-5 weeks after each cycle and the patient will be visited to decide about the next cycle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Department of Namazi Hospital
Full name of responsible person
Tahereh Ghaedian
Street address
Department of Nuclear Medicine, Namazi hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4835
Email
tghaedian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadhashem Hashempur
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2710
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
30
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
Parsisotope Company
Full name of responsible person
Mohammadreza Davarpanah
Street address
No 88, West 23 alley, Janbazan Blvd, South Sheikh Bahai street
City
Tehran
Province
Tehran
Postal code
7193613311
Phone
+98 21 8822 1115
Email
info@prsind.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Parsisotope Company
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Ghaedian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Department of nuclear medicine, Namazi hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4835
Email
tghaedian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Ghaedian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Department of nuclear medicine, Namazi hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 17 3647 4835
Email
tghaedian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Ghaedian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Department of nuclear medicine, Namazi hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4835
Email
tghaedian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be potentially available for sharing after being anonymized
When the data will become available and for how long
One year after article publish
To whom data/document is available
Considering the pilot nature of the study, the data will be shared only with academic and scientific centers for investigational purposes.
Under which criteria data/document could be used
Only for research purposes with proper citation
From where data/document is obtainable
Corresponding author of published article
What processes are involved for a request to access data/document
Sending a request via email to corresponding author
Assessment request eligibility
If accepted, the data will be shared till 1 months