Cervical CancerPhase 2AMIGONCT01399658
Image-Guided Gynecologic Brachytherapy
A Phase 2 study testing Image-guided brachytherapy and 3'-Deoxy-3'-18f-Fluorothymidine in people with Cervical Cancer and Uterine Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer, Vaginal Cancer
- What is being tested?
- Image-guided brachytherapy and 3'-Deoxy-3'-18f-Fluorothymidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
- Life expectancy > 6 months
- MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Who cannot join
- Uncontrolled intercurrent illness
- Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
Read the detailed description
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.
- Being tested
- Image-guided brachytherapy, 3'-Deoxy-3'-18f-Fluorothymidine
- Keywords
- Brachytherapy, Gynecological cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided brachytherapyProcedure or surgery
Also called internal radiation therapy, implant radiation
MRI-guided application of brachytherapy
3'-Deoxy-3'-18f-FluorothymidineDrug
Assessing tumor proliferation in Gynecologic cancer
| Study group | Role | What they receive |
|---|---|---|
| Image-Guided Brachytherapy | Experimental | Image-guided brachytherapy Receives: Procedure: Image-guided brachytherapy; Drug: 3'-Deoxy-3'-18f-Fluorothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Doses Given
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Measured: Measured while on treatment, up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin King, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Martin King, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399658
- Sponsor's protocol ID
- 11-098
- Acronym
- AMIGO
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2011
- Last updated
- 14 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)
- ClinicalTrials.gov ID
- NCT01399658
- Acronym / sponsor ID
- AMIGO / 11-098
- Keywords
- Brachytherapy, Gynecological cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.
Detailed description
The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.
Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Brachytherapy | Experimental | Procedure: Image-guided brachytherapy, Drug: 3'-Deoxy-3'-18f-FluorothymidineImage-guided brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
- Life expectancy > 6 months
- MRI of the pelvis and/or PET-CT within 4 months prior to entering study
Key exclusion criteria (2 listed)
- Uncontrolled intercurrent illness
- Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
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 |
|---|---|---|
| Image-guided brachytherapyAlso: internal radiation therapy, implant radiationMRI-guided application of brachytherapy | Procedure or surgery | Image-Guided Brachytherapy |
| 3'-Deoxy-3'-18f-FluorothymidineAssessing tumor proliferation in Gynecologic cancer | Drug | Image-Guided Brachytherapy |
Primary outcome
Mean Doses Given
Time frame: Measured while on treatment, up to 2 months.
Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Martin King, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Image-guided brachytherapy and 3'-Deoxy-3'-18f-Fluorothymidine in people with Cervical Cancer and Uterine Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
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 3 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 14 Mar 2023. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Doses Given (time frame: Measured while on treatment, up to 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2023.