Trials / Completed
CompletedNCT01391065
MR- PET Guided Biologically Optimised Interstitial Brachytherapy
MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Tata Memorial Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | MR PET Guided Brachytherapy |
Timeline
- Start date
- 2011-02-23
- Primary completion
- 2019-02-01
- Completion
- 2019-10-04
- First posted
- 2011-07-11
- Last updated
- 2020-04-07
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT01391065. Inclusion in this directory is not an endorsement.