Cervical CancerEarly Phase 1NCT01779128
PET-CT vs. Integrated MR-PET Scanning of GYN Cancers
A Early Phase 1 study testing PET-CT and MR-PET in people with Cervical Cancer and Endometrial Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is an imaging pilot study. Imaging pilot studies explore the potential benefit of one imaging approach compared to another clinically accepted approach. Such studies serve to understand how feasible an approach may be and whether it is worth pursuing in formal and larger clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- What is being tested?
- PET-CT and MR-PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed cervical, endometrial or ovarian cancer
- Able to undergo extra-peritoneal or laparoscopic lymph node sampling
- Suitable candidate for surgery
Who cannot join
- Previous pelvic or abdominal lymphadenectomy
- Evidence of prior pelvic radiation therapy
- Renal dysfunction
- Electrical implants
- Ferromagnetic implants
- Pregnant or breastfeeding
Show all 9Show fewer
- Pre-existing medical conditions or claustrophobic reactions or any greater than normal potential for cardiac arrest as determined by treating oncologist
- Unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by physical examination and medical history
- Outside circumstances that interfere with the completion of the imaging studies or required follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
Michael Birrer, MD, PhD, 617-726-1941, mbirrer@partners.org
Michael Birrer, MD, PhD
About this study
Official title: Comparing Preoperative PET-CT With Integrated MR-PET Scanning of Gynecologic Cancers
This research study is an imaging pilot study. Imaging pilot studies explore the potential benefit of one imaging approach compared to another clinically accepted approach. Such studies serve to understand how feasible an approach may be and whether it is worth pursuing in formal and larger clinical trials. Researchers of this study believe that simultaneous Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer additional imaging information to improve cancer detection.
MRI and PET are two tests that allow us to take pictures of the body and "look inside" the body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body. The PET scanner makes pictures by using special dyes that "light up" inside the body. PET scans use radiation, similar to the radiation in a standard x-ray. We routinely use both tests to diagnose various types of cancer. As of now, the combination of PET and computed tomography (CT) has been considered a standard of care imaging approach for various cancers.
Read more
Until recently, MRI and PET tests were done separately. Now there is a new type of test called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET tests at the same time. We would like to find out if the MR-PET scanner can produce better and clearer images (pictures) of tumors and information about them inside of the body.
This new MR-PET scanner is approved by the US FDA. However, some of the computer programs that tell the machine how to acquire and combine the test results are new and experimental. Experimental means that some of the computer programs are not approved by the FDA. This means that they can only be used in research studies. The MR-PET scanner has been previously used in a few human participants.
Read the detailed description
If you agree to participate in this study you will be asked to undergo some tests and procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include a medical history, blood tests and a urine pregnancy test. If these tests show that you are eligible to participate in the research study, you will be able to undergo a one time MR/PET imaging session on the same day you are scheduled for a PET/CT. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
We will verify that your doctor has ordered a standard PET/CT scan as part of your regular medical care. You will have that PET/CT scan at teh main MGH Boston campus. As part of the PET/CT scan, you will have an injection of a radioactive material into your vein. The radioactive material consists of glucose (sugar) that has been labeled as radioactive. Your own doctor, the radiologist performing imaging and/or the PET/CT staff will explain this type of scan to you in more detail. You will be asked to sign a separate consent form for that PET/CT scan.
PET/CT scanning can make pictures of structures inside the body because the injected radioactive material "lights up" on the pictures. This shows us details of organs, tissues, blood vessels, and other structures in your body. The radioactive material breaks down and leaves your body gradually through the urine. It takes about a day for the radioactive material to exit your body completely. You will not receive an additional injection of radioactive material for this MR-PET study.
You will have the standard PET/CT procedures and the study MR-PET scans on the same day. After you have the PET/CT scan, you will travel to the MGH Charlestown facility for the study MR-PET scan. It takes about 15 minutes to travel between the main MGH campus and the MGH Charlestown facility. Although you must fast (no eating or drinking) before the PET/CT scan, you do not have to fast before the MR-PET scan. You will be able to have a snack before the scan, if you wish.
During the MR-PET Procedure: We will ask you some standard questions to make sure that you can safely have an MRI. It is important that you take off anything that contains metal, such as jewelry, piercings or zippers. You may need to put on a hospital gown. We will also ask you to empty your bladder before the scan.
We will ask you to lie down on a narrow table. The table will slide you into the center of the very large MRI scanner, which is shaped like a tunnel. The tunnel is a little wider than your body. You will need to lie very still during the scanning process.
In order to help hold your head still, we may place foam pillows under and around your head. The scanner makes loud banging and beeping noises when making pictures, so we will give you earplugs or headphones to protect your ears.
The top and sides of the tunnel will be close to your face and body, which can make some people uncomfortable. If you have ever experienced a fear of small spaces (claustrophobia), please tell the MRI staff. You will be able to hear and speak to the research staff at all times during the scan. We can stop the scan at any time, if needed.
First, we will make some pictures of your brain and/or whole body.
The PET scan will take place at the same time as the MRI scan using our new MR-PET scanner. You will not need another injection of radioactive material for our MR-PET scan.
During scanning, we may ask you to do some activities with your hands, look at pictures, listen to some sounds, or do other things. We will make pictures of your brain during these activities to test different settings on the scanner.
After your study scans are complete, your time in the study will be over. The whole testing session will take up to one and a half hours. You may feel a little bit tired afterwards, so you can rest a bit before leaving the scanning area.
You will be in this research study for about up to one month-this includes the waiting period until pathology results from the surgery are back. Your actual participation in the study will only involve that one day when you receive both the PET/CT and PET/MR.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- Being tested
- PET-CT, MR-PET
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTProcedure or surgery
MR-PETProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | PET/CT Scan MR-PET Scan Receives: Procedure: PET-CT; Procedure: MR-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT
To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus PET/CT imaging in identifying metastases to pelvic lymph nodes, abdominal lymph nodes, or beyond in participants with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
Measured: 2 years
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT
To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus FDG-PET/CT imaging in identifying contralateral ovary involvement, metastases to peritoneum and distinguishing benign (e.g., endometriosis) from malignant lesions in all participants with ovarian cancer
Measured: 2 years
Secondary outcomes (2)
Evaluate Additive Diagnostic Value of MRI Fusion
To evaluate the additive diagnostic value of MRI fusion (MR/PET) compared with PET scanning alone in the identification of metastases to pelvic (obturator, external iliac), abdomen (common iliac, para-aortic, and para-caval), and combined (all regions) lymph nodes in participants with locoregionally advanced cervical carcinoma, high-risk endometrial carcinoma or ovarian carcinoma.
Measured: 2 years
Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease
To determine the percentage of participants with locoregionally advanced cervical carcinoma, high-risk endometrial cancer, or ovarian carcinoma in whom MR/PET (relative to PET/CT) detects biopsy proven disease outside the abdominal or pelvic lymph nodes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Birrer,M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Michael Birrer, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779128
- Sponsor's protocol ID
- 12-233
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Preoperative PET-CT With Integrated MR-PET Scanning of Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT01779128
- Acronym / sponsor ID
- 12-233
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- First posted
- 30 Jan 2013 (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.
This research study is an imaging pilot study. Imaging pilot studies explore the potential benefit of one imaging approach compared to another clinically accepted approach. Such studies serve to understand how feasible an approach may be and whether it is worth pursuing in formal and larger clinical trials. Researchers of this study believe that simultaneous Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) imaging will offer additional imaging information to improve cancer detection.
MRI and PET are two tests that allow us to take pictures of the body and "look inside" the body without surgery. The MRI scanner uses a powerful magnet to make a picture of the body. The PET scanner makes pictures by using special dyes that "light up" inside the body. PET scans use radiation, similar to the radiation in a standard x-ray. We routinely use both tests to diagnose various types of cancer. As of now, the combination of PET and computed tomography (CT) has been considered a standard of care imaging approach for various cancers.
Until recently, MRI and PET tests were done separately. Now there is a new type of test called MR-PET that combines both MRI and PET test results. This scanner uses both MRI and PET tests at the same time. We would like to find out if the MR-PET scanner can produce better and clearer images (pictures) of tumors and information about them inside of the body.
This new MR-PET scanner is approved by the US FDA. However, some of the computer programs that tell the machine how to acquire and combine the test results are new and experimental. Experimental means that some of the computer programs are not approved by the FDA. This means that they can only be used in research studies. The MR-PET scanner has been previously used in a few human participants.
Detailed description
If you agree to participate in this study you will be asked to undergo some tests and procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include a medical history, blood tests and a urine pregnancy test. If these tests show that you are eligible to participate in the research study, you will be able to undergo a one time MR/PET imaging session on the same day you are scheduled for a PET/CT. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
We will verify that your doctor has ordered a standard PET/CT scan as part of your regular medical care. You will have that PET/CT scan at teh main MGH Boston campus. As part of the PET/CT scan, you will have an injection of a radioactive material into your vein. The radioactive material consists of glucose (sugar) that has been labeled as radioactive. Your own doctor, the radiologist performing imaging and/or the PET/CT staff will explain this type of scan to you in more detail. You will be asked to sign a separate consent form for that PET/CT scan.
PET/CT scanning can make pictures of structures inside the body because the injected radioactive material "lights up" on the pictures. This shows us details of organs, tissues, blood vessels, and other structures in your body. The radioactive material breaks down and leaves your body gradually through the urine. It takes about a day for the radioactive material to exit your body completely. You will not receive an additional injection of radioactive material for this MR-PET study.
You will have the standard PET/CT procedures and the study MR-PET scans on the same day. After you have the PET/CT scan, you will travel to the MGH Charlestown facility for the study MR-PET scan. It takes about 15 minutes to travel between the main MGH campus and the MGH Charlestown facility. Although you must fast (no eating or drinking) before the PET/CT scan, you do not have to fast before the MR-PET scan. You will be able to have a snack before the scan, if you wish.
During the MR-PET Procedure: We will ask you some standard questions to make sure that you can safely have an MRI. It is important that you take off anything that contains metal, such as jewelry, piercings or zippers. You may need to put on a hospital gown. We will also ask you to empty your bladder before the scan.
We will ask you to lie down on a narrow table. The table will slide you into the center of the very large MRI scanner, which is shaped like a tunnel. The tunnel is a little wider than your body. You will need to lie very still during the scanning process.
In order to help hold your head still, we may place foam pillows under and around your head. The scanner makes loud banging and beeping noises when making pictures, so we will give you earplugs or headphones to protect your ears.
The top and sides of the tunnel will be close to your face and body, which can make some people uncomfortable. If you have ever experienced a fear of small spaces (claustrophobia), please tell the MRI staff. You will be able to hear and speak to the research staff at all times during the scan. We can stop the scan at any time, if needed.
First, we will make some pictures of your brain and/or whole body.
The PET scan will take place at the same time as the MRI scan using our new MR-PET scanner. You will not need another injection of radioactive material for our MR-PET scan.
During scanning, we may ask you to do some activities with your hands, look at pictures, listen to some sounds, or do other things. We will make pictures of your brain during these activities to test different settings on the scanner.
After your study scans are complete, your time in the study will be over. The whole testing session will take up to one and a half hours. You may feel a little bit tired afterwards, so you can rest a bit before leaving the scanning area.
You will be in this research study for about up to one month-this includes the waiting period until pathology results from the surgery are back. Your actual participation in the study will only involve that one day when you receive both the PET/CT and PET/MR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Procedure: PET-CT, Procedure: MR-PETPET/CT Scan MR-PET Scan |
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 confirmed cervical, endometrial or ovarian cancer
- Able to undergo extra-peritoneal or laparoscopic lymph node sampling
- Suitable candidate for surgery
Key exclusion criteria (9 listed)
- Previous pelvic or abdominal lymphadenectomy
- Evidence of prior pelvic radiation therapy
- Renal dysfunction
- Electrical implants
- Ferromagnetic implants
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 |
|---|---|---|
| PET-CT | Procedure or surgery | Experimental Arm |
| MR-PET | Procedure or surgery | Experimental Arm |
Primary outcome
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT
Time frame: 2 years
To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus PET/CT imaging in identifying metastases to pelvic lymph nodes, abdominal lymph nodes, or beyond in participants with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. FDG-PET/CT
Time frame: 2 years
To evaluate the diagnostic sensitivity and specificity of preoperative MR/PET versus FDG-PET/CT imaging in identifying contralateral ovary involvement, metastases to peritoneum and distinguishing benign (e.g., endometriosis) from malignant lesions in all participants with ovarian cancer
2 secondary outcomes
Evaluate Additive Diagnostic Value of MRI Fusion
Time frame: 2 years
Determine Percentage of Participants in Whom MR/PET (relative to PET/CT) Detects Biopsy Proven Disease
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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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.
Michael Birrer, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PET-CT and MR-PET in people with Cervical Cancer and Endometrial Cancer, run by Massachusetts General Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 30 Jan 2013. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Birrer, MD, PhD (6177261941, mbirrer@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Diagnostic Sensitivity and Specificity of Preoperative MR/PET vs. PET/CT (time frame: 2 years). The study lists 2 primary outcomes in all. 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 30 Jan 2013.