MR-PET Guided Biologically Optimised Interstitial Brachytherapy
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Diffusion Weighted MRI, FLT PET, F-Miso PET, Image Guided Brachytherapy, Cervix, Postoperative Residual Disease/Postoperative recurrences
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Intervention
Name: MR PET Guided Brachytherapy
Type: Radiation
Overall Status
Recruiting
Summary
The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).

The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.

In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.
Detailed Description
Aims

Stage I

Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.

Stage II:

Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.

Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Age > 18 years.

- ECOG 0 or 1.

- Residual/ Recurrent tumor after hysterectomy of cervical cancer.

- No visceral metastasis.

- No known contraindication to contrast enhanced MRI/PET scan.

- Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion Criteria:

- Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.

- Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).
Location
Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
Navi Mumbai, Maharashtra, India
Status: Recruiting
Contact: Dr Supriya Chopra, MD - 91-22-27405000 - schopra@actrec.gov.in
Start Date
March 2011
Completion Date
March 2017
Sponsors
Tata Memorial Hospital
Source
Tata Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page