Clinical trial · Interventional
MR- PET Guided Biologically Optimised Interstitial Brachytherapy
MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR PET Guided Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- The study arm will undergo baseline multifunctional PET and MRI scans, before brachytherapy and at follow up
- interventionNames
- Radiation: MR PET Guided Brachytherapy
Primary outcomes (1)
- measure
- Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
- timeFrame
- 3 months after treatment completion
Secondary outcomes (1)
- measure
- Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy
- timeFrame
- 2 years after treatment conclusion
- description
- Stage II involves dose modulated brachytherapy wherein higher dose will be delivered to biologically high risk target volume. Saftey will be assessed initially by an interim analysis undertaken at 50 % accrual(median follow up 1 yr). If incidence of grade III-IV rectal and bladder toxicity \>15% than the trial will be stopped else continued till target accrual. The technique will be considered to be safe if Grade III bladder and bowel toxicity remain to be under 15%.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDChopra S, Engineer R, Shah S, Shukla R, Dora T, Gupta P, Paul SN, Popat P, Swamidas J, Mahantshetty U, Varghese L, Gupta S, Rangrajan V, Shrivastava S. MRI- and PET-Guided Interstitial Brachytherapy for Postsurgical Vaginal Recurrences of Cervical Cancer: Results of Phase II Study. Int J Radiat Oncol Biol Phys. 2020 Feb 1;106(2):310-319. doi: 10.1016/j.ijrobp.2019.10.037. Epub 2019 Nov 1. PMID 31682968