Cervical CancerMR-PET BrachyNCT01391065
MR- PET Guided Biologically Optimised Interstitial Brachytherapy
A study testing MR PET Guided Brachytherapy in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- MR PET Guided Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 23 Feb 2011to 4 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
India1 site
Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
Navi Mumbai, Maharashtra, 410210
About this study
Official title: MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
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.
Read the 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
- Cervical Cancer
- Being tested
- MR PET Guided Brachytherapy
- Keywords
- Diffusion Weighted MRI, FLT PET, F-Miso PET, Image Guided Brachytherapy, Cervix, Postoperative Residual Disease/Postoperative recurrences
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR PET Guided BrachytherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | The study arm will undergo baseline multifunctional PET and MRI scans, before brachytherapy and at follow up Receives: Radiation: MR PET Guided Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
Measured: 3 months after treatment completion
Secondary outcomes (1)
Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy
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%.
Measured: 2 years after treatment conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study start23 Feb 2011
- Primary completionFeb 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Supriya Sastri (chopra), Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391065
- Sponsor's protocol ID
- TMH-IRB 843
- Acronym
- MR-PET Brachy
- Status last verified
- Apr 2020
- First submitted
- 1 Jul 2011
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chopra 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.
PubMed 31682968
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers
- ClinicalTrials.gov ID
- NCT01391065
- Acronym / sponsor ID
- MR-PET Brachy / TMH-IRB 843
- Conditions
- Cervical Cancer
- Keywords
- Diffusion Weighted MRI, FLT PET, F-Miso PET, Image Guided Brachytherapy, Cervix, Postoperative Residual Disease/Postoperative recurrences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 23 Feb 2011 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: MR PET Guided BrachytherapyThe study arm will undergo baseline multifunctional PET and MRI scans, before brachytherapy and at follow up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR PET Guided Brachytherapy | Radiation | 1 |
Primary outcome
Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
Time frame: 3 months after treatment completion
1 secondary outcome
Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy
Time frame: 2 years after treatment conclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 31682968Chopra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR PET Guided Brachytherapy in people with Cervical Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Response in spatial reference to High Risk GTV (as identified by functional imaging) (time frame: 3 months after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01391065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.