| CTRI Number |
CTRI/2018/04/013455 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of usefulness of [18F] Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the initial staging and assessment of response to treatment in locally advanced breast cancer |
|
Scientific Title of Study
|
A prospective study of utility of [18F] Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in the initial staging and response assessment of locally advanced breast cancer patients receiving neoadjuvant chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narendra H |
| Designation |
Associate professor |
| Affiliation |
Sri Venakteswara Institute of Medical Sciences Tirupati |
| Address |
Department of Surgical oncology
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
917382629699 |
| Fax |
|
| Email |
drnarendrah@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Narendra H |
| Designation |
Associate professor |
| Affiliation |
Sri Venakteswara Institute of Medical Sciences Tirupati |
| Address |
Department of Surgical oncology
SVIMS
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
917382629699 |
| Fax |
|
| Email |
drnarendrah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sivanath Reddy Gajjala |
| Designation |
Senior resident |
| Affiliation |
Sri Venakteswara Institute of Medical Sciences Tirupati |
| Address |
Department of Surgical oncology
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
917382629699 |
| Fax |
|
| Email |
drgajjala@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri Venkateswara Institute of Medical Sciences, alipirir road, Tirupati 517507 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Alipiri road, Tirupati Chittoor AP india |
| Type of Sponsor |
Research institution and hospital |
|
|
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 narendra |
Sri Venakateswara Institute of Medical Sciences |
Aalipiri road Ttirupati
Chittoor
ANDHRA PRADESH |
7382629699
drnarendrah@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVIMS Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with locally advanced breast cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PET/CT |
Whole body 18FDG PET/CT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
biopsy proven locally advanced breast cancer women |
|
| ExclusionCriteria |
| Details |
Patients with early breast cancer or found to have metastatic disease on conventional imaging will be excluded from the study. Patients who have already received treatment elsewhere will be excluded. Male patients with breast cancer will not be included. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the utility of FDG PET/CT in initial staging of locally advanced breast cancer.
2. To compare FDG PET/CT with conventional methods in staging of locally advanced breast cancer
3. To evaluate the role of FDG PET/CT in predicting pathological response to neoadjuvant chemotherapy in comparison to other methods
4. Usefulness of PET/CTin selection of patients for breast conservation surgery vs mastectomy after NACT
|
February 2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Usefulness of PET/CTin selection of patients for breast conservation surgery vs mastectomy after NACT
|
over 20 month period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2013 |
| Date of Study Completion (India) |
28/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast cancer is the most common cancer among urban women and second among rural women in India. Majority of the women present at an advanced stage. Patients presenting clinically with LABC are evaluated with traditional imaging methods to look for metastatic disease. One drawback of the conventional imaging modalities is the extent to which they may underestimate the metastatic disease. PET/CT combines the metabolic imaging with the anatomical imaging and can be more valuable is detecting metastatic disease than the conventional methods. The standard treatment of locally advanced breast cancer is neoadjuvant chemotherapy followed by locoregional treatment. Tools to assess the response of neoadjuvant chemotherapy include clinical assessment, CT, MRI, and mammogram. All of these modalities are far from accurate. Again PET/CT by combining metabolic imaging with anatomical information can prove more useful. hence the present study looks to predict the utility of PET/CT in detecting the site of metastasis and assessing the response to chemotherapy. |