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

STUDY RATIONALE:xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 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