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CTRI Number  CTRI/2012/09/002966 [Registered on: 06/09/2012] Trial Registered Prospectively
Last Modified On: 05/09/2012
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective Observational Study 
Study Design  Other 
Public Title of Study   Management and prognosis of breast cancer through FDG PET/CT  
Scientific Title of Study   To assess the Indications of 18[F] FDG PET/CT in Breast cancer patients-study based on the patients referred to “The Nuclear Medicine Department” of Max Super Speciality Hospital 2, Press Enclave Road, Saket, New Delhi -110017 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MAX/RETRO/CABR/V-1.2  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  priya gupta 
Designation  student 
Affiliation  DIPSAR 
Address  DELHI INSTITUTE OF SCIENCE AND RESEARCH (DIPSAR), PUSHP VIHAR, NEW DELHI

New Delhi
DELHI
110017
India 
Phone    
Fax    
Email  priya_charu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrBPSrinivasan 
Designation  Director (DIPSAR) 
Affiliation  DIPSAR 
Address  DIPSAR, PUSHP VIHAR, NEW DELHI

South
DELHI
110017
India 
Phone    
Fax    
Email  bpsrinivasan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  priya gupta 
Designation  student 
Affiliation  DIPSAR 
Address  DIPSAR, PUSHP VIHAR, NEW DELHI


DELHI
110017
India 
Phone    
Fax    
Email  priya_charu@hotmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Not applicable Thesis Protocol  
Address  Not applicable( Thesis Protocol ) 
Type of Sponsor  Other [Not applicable( Thesis Protocol )] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPankaj Dougall  Max Super Speciality Hospital, Saket  Nuclear Medicine Department of Max Super Speciality Hospital 2, Press Enclave Road, Saket, New Delhi -110017
New Delhi
DELHI 		 9810042316

pdougall@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Breast Cancer (Retrospective data of Breast Cancer Patients will be collected),  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  0.00 Year(s)
Gender  Female 
Details  Female breast cancer patients referred for 18[F] FDGPET/CT scan in the Nuclear Medicine Department of Max Super Speciality Hospital.  
 
ExclusionCriteria 
Details  Patient clinical data not available. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the indication for 18[F] FDG PET/CT for breast cancer patients, used by Oncologist in Max Super Speciality Hospital:
a)Diagnosis
b)Staging
c)Recurrence/Metastasis (Restaging)
d)Treatment response evaluation
e)Radiation treatment response
 		 Indication of 18[F] FDG PET/CT for breast cancer patients:
a)Diagnosis
b)Staging
c)Recurrence/Metastasis (Restaging)
d)Treatment response evaluation
e)Radiation treatment response
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To determine 18[F] FDG PET/CT effectiveness in the evaluation of chemotherapy response by calculating the percentage decrease in SUV value from the baseline value (Pre-therapy scan).
2. To determine the impact of 18[F] FDG PET/CT on the treatment management plan, whether altered or supported.
3. To determine the most common metastatic site in the metastatic breast cancer patients.
 		 1.Percentage decrease in SUV value (post-therapy scan) from the baseline value (Pre-therapy scan).
2.Change in the treatment management plan.
3. Most common metastatic site in the metastatic breast cancer patients.
 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/10/2012 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Publication of the results of the study shall be within the sole discretion of chief guide, in the publication subject identify will not be revealed. Confidentiality of the subject would be maintained. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

   STUDY RATIONALE:

 

 The management and prognosis of breast cancer depends on a variety of factors, including tumour size, local spread and distant metastasis. The detection of axillary lymph nodes and distant metastases is extremely important in deciding how to treat breast cancer patients. Also the functional imaging plays an important role in evaluating the response to therapy. 18[F] FDG PET/CT may provide an early indication of biologic changes in response to targeted therapy that may indicate that the chosen drug has successfully hit the target and perhaps more important, indicate when the targeted therapy has not impacted the cancer.

 

STUDY OBJECTIVE:

 

Primary objective: 

 

  •      To assess the Indications of 18[F] FDG PET/CT in breast cancer patients referred to “The Nuclear Medicine Department” of Max Super Speciality Hospital.

 

     Secondary objective: 

  • To evaluate chemotherapeutic response in patients with recurrent or metastatic breast cancer receiving only chemotherapy for metastatic lesion.
  • To evaluate the impact of 18[F] FDG PET/CT on the treatment management plan.

    STUDY DESIGN:    

     This is a Retrospective observational Study to be done on breast cancer patients referred for 18[F] FDG PET/CT scans in “The Nuclear Medicine Department” of Max Super Speciality Hospital from November 2009 to March 2012.

18[F] FDG PET/CT scan reports and medical records of female breast cancer patients will be retrospectively reviewed for the study.

SUBJECT SELECTION:   Study specific subject selection criteria are:

  •     Inclusion criteria:   Female breast cancer patients referred for 18[F] FDG PET/CT scan  In “The Nuclear Medicine Department” of Max Super Speciality Hospital.                                 
  •     Exclusion criteria: Patient clinical data not available.

SAMPLE SIZE:  500 18[F] FDG PET/CT scans of breast cancer patients will be taken.

 STUDY PROCEDURE:

From 2,500 18[F] FDG PET/CT scans, reported in “The Nuclear Medicine Department” of Max Super Speciality Hospital, Saket, 18[F] FDG PET/CT scans referred for breast cancer patients will be separated out and their indications for 18[F] FDG PET/CT and their medical records will be studied and following details will be recorded in the data collection sheet (Appendix-I).

 Scan reports and Medical records provide the following data:

1)      Age at the time of scan

2)      Sex

3)      Menopausal status

4)      Scan date

5)      Indications for FDG PET/CT scan

6)      Histobiopsy report

7)      Tumour type, size and nodal status

8)      Detection of Metastatic sites

9)      Number of lesions in each site

10)  Standard uptake value (SUVMAX)

11)  Impression of FDG PET/CT scans both baseline and post therapy scans

12)  Treatment plan after last PET (Altered / Supported)

 

STUDY DURATION:

     Data of female breast cancer patients, who were treated according to the clinical protocol in “The Nuclear Medicine Department” of Max Super Speciality Hospital, Saket from November 2009 to March 2012, will be collected.

     Stage 1…Review of medical records 

     Stage 2…Data collection and Data analysis (1-2 months)

     Stage 3…Presentation and publication 

STUDY ENDPOINTS(Outcome):

 Primary outcome:

  • To determine the indication for 18[F] FDG PET/CT for breast cancer patients, used by Oncologist in Max Super Speciality Hospital:

a)      Diagnosis

b)      Staging

c)      Recurrence/Metastasis (Restaging)

d)     Treatment response evaluation

e)      Radiation treatment response

Secondary outcome:

  • To determine 18[F] FDG PET/CT effectiveness in the evaluation of chemotherapy response by calculating the percentage decrease in SUV value from the baseline value (Pre-therapy scan).
  • To determine the impact of 18[F] FDG PET/CT on the treatment management plan, whether altered or supported.
  • To determine the most common metastatic site in the metastatic breast cancer patients

DATA COLLECTION

Hard copy of CRF

 

 

 

 

 

 
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