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MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers


Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers


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


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).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Local Response in spatial reference to High Risk GTV (as identified by functional imaging)

Outcome Time Frame:

3 months after treatment completion

Safety Issue:

No

Authority:

Data Monitoring Committee:

Study ID:

TMH-IRB 843

NCT ID:

NCT01391065

Start Date:

March 2011

Completion Date:

March 2017

Related Keywords:

  • Cervical Cancer
  • Diffusion Weighted MRI
  • FLT PET
  • F-Miso PET
  • Image Guided Brachytherapy
  • Cervix
  • Postoperative Residual Disease/Postoperative recurrences
  • Uterine Cervical Neoplasms

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