| CTRI Number |
CTRI/2021/05/033776 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
16/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
PET scan for measuring response in lymphoma of brain |
|
Scientific Title of Study
|
A prospective study to evaluate the role of PET-CT in response evaluation of patients of primary CNS lymphoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhausaheb Bagal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Centre, Mumbai. |
| Address |
Room No 1104, 11th floor, HBB block, Tata Hospital, Parel, Mumbai.
Room no 211, Tata Hospital, ACTREC, Kharghar, Navi Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhausaheb Bagal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Centre, Mumbai. |
| Address |
Room No 1104, 11th floor, HBB block, Tata Hospital, Parel, Mumbai.
Room no 211, Tata Hospital, ACTREC, Kharghar, Navi Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhausaheb Bagal |
| Designation |
Professor and consultant Medical Oncologist |
| Affiliation |
Tata Memorial Centre, Mumbai. |
| Address |
Room No 1104, 11th floor, HBB block, Tata Hospital, Parel, Mumbai.
Room no 211, Tata Hospital, ACTREC, Kharghar, Navi Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177210 |
| Fax |
|
| Email |
bagalbp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Mumbai |
| Address |
Tata Hospital, Dr. E Borges Road, Parel, mumbai.
Pin 400012 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhausaheb Bagal |
Tata Memorial Centre |
Room no 81, Main building, Department of Medical Oncology, Tata Hospital, Dr. E Borges road, Parel, Mumbai.
410210
Mumbai
MAHARASHTRA |
02224177210
bagalbp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MRI brain |
MRI will be done as per standard recommendations by IPCG at 2,4 and 6 months of treatment. |
| Intervention |
PET-CT scan |
PET-CT scan for response assessment will be done and compared with MRI brain at time point 2,4 and 6 months whenever a MRI brain is planned. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of PCNSL
2. Receiving high dose methotrexate based induction therapy
3. Patient available for response assessment MRI & PET-CT Brain post induction chemotherapy
4. Patient able to understand & sign the consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients who cannot complete the high dose methotrexate based induction chemotherapy due to toxicity or other reasons except progression .
2.Patient with any contrast allergies or hypersensitivities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of PET-CT as compared to MRI (gold standard for response assessment) |
2,4 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prognostic value of PET response |
2, 4 and 6 months |
| Prognostic value of MTV and TLG |
At start that time point "0" |
| Utility of PET-MRI fusion |
2,4 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Primary CNS lymphoma comprises 2-3 % of all Non Hodgkin’s Lymphoma [1,2].With standard High dose Methotrexate based regimens the complete response rate is 66% .Primary CNS lymphomas have poor overall outcomes specifically those who failed to attains complete remission with Hd Mtx based regimens. Contrast enhanced Magnetic resonance imaging (MRI) is the standard technique used in the initial evaluation and assessment of the response of the primary central nervous system lymphoma (PCNSL). However it has its own limitations 1. Limitations in interpreting tumour activity after chemotherapy & radiation therapy. 2. Limitations of interpreting the non-enhancing lesion of PCNSL & specifically the Lymphomatosis cerebri. 3. Contrast enhancement in MRI is due to the altered blood brain barrier which can be due to either tumour or chemo/radiotherapy or surgical procedures which cannot be differentiated. PET-CT is routinely used in staging and response assessment of systemic lymphoma & it predicts long term outcome of the disease . Interim(midcycle) PET CT have role in modification of therapies in systemic lymphoma. Several studies have analysed the role of PET CT in the initial assessment of PCNSL & their good correlation with MRI [3,4,5] .However, only few studies have analysed the role of PET CT in the response assessment. This is a study to determine the utility of PET-CT for response evaluation in patients of PCNSL at interim & post treatment completion & its prognostic significance. In this study patients with diagnosis of PCNSL and receiving standard induction chemotherapy will be included in the analysis. Patients will undergo response assessment with MRI brain (P+ Contract) as per standard practice after 2 cycle & after 4 cycles of induction chemo . For the study purpose, patients will undergo PET-CT after 2 cycles and 4 cycles of induction. The sensitivity and specificity of PET-CT based response will be calculated with MRI response assessment used as reference standard. Patients will be followed as per routine clinical practice after this and outcomes will be recorded for disease free and overall survival. |