MR- PET Guided Biologically Optimised Interstitial Brachytherapy (MR-PET Brachy)

Tata Memorial Hospital

Status

Completed

Conditions

Cervical Cancer

Treatments

Radiation: MR PET Guided Brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01391065

TMH-IRB 843

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).