Cervix CarcinomaNCT01759355
Hybrid PET/MR in the Therapy of Cervical Cancer
An observational study of Cervix Carcinoma and Cervical Squamous Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Carcinoma, Cervical Squamous Cell Carcinoma, Cervical Adenosquamous Carcinoma
- What is being tested?
- FDG PET/MR
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 28 May 2020
- Phase
- Observational
- 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
Study population: UNC Hospitals
Who may be able to join
- ≥ 18 years of age
- Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
- Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b
- Scheduled to undergo standard of care PET/CT for baseline assessment of disease
- Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist
- If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first PET/MRI
- Informed consent reviewed and signed
Who cannot join
- History of sever reaction to contrast-enhanced CT scan
- Inability to tolerate MRI (e.g., inability to lie flat > 1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
- Poorly controlled diabetes mellitus
- Creatinine > 1.4 mg/dL or GFR < 30 mL/min
- Body Mass Index (BMI) > 35
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- Active vaginal bleeding requiring packing and emergent radiation therapy
- Pregnant or lactating female
- History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years
- Substance abuse, medical, psychological, or social conditions that may interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.
Read the detailed description
The primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid PET/MR images for patients diagnosed with cervical cancer.
- Being tested
- FDG PET/MR
- 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.
FDG PET/MRProcedure or surgery
Also called FDG Positron Emission Tomography/Magnetic Resonance Scan
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans. Receives: Procedure: FDG PET/MR | |
| Chemoradiation | Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans. Receives: Procedure: FDG PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who successfully complete PET/MR scans at all study time-points
Measured: 2-3 months post-treatment
Secondary outcomes (4)
Sensitivity of PET/MR for baseline disease assessment
Estimated proportion of subjects with disease (positive pathology or PET/CT) that have positive PET/MR scans.
Measured: pre-treatment
Specificity of hybrid PET/MR for baseline disease assessment
Proportion of subjects without disease (negative pathology or PET/CT) that have negative PET/MR scans.
Measured: pre-treatment
Accuracy of hybrid PET/MR for baseline disease assessment
Proportion of correct assessments among total population
Measured: pre-treatment
Detection of disease with PET/MR at each time point
Measured: pre-treatment to 2-3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2012
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Oldan, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759355
- Sponsor's protocol ID
- LCCC1221
- Status last verified
- Dec 2021
- First submitted
- 17 Dec 2012
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01759355
- Acronym / sponsor ID
- LCCC1221
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 3 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 is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.
Detailed description
The primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid PET/MR images for patients diagnosed with cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: FDG PET/MRParticipants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans. |
| Chemoradiation | – | Procedure: FDG PET/MRParticipants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UNC Hospitals
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
- Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b
- Scheduled to undergo standard of care PET/CT for baseline assessment of disease
- Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist
Key exclusion criteria (10 listed)
- History of sever reaction to contrast-enhanced CT scan
- Inability to tolerate MRI (e.g., inability to lie flat > 1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
- Poorly controlled diabetes mellitus
- Creatinine > 1.4 mg/dL or GFR < 30 mL/min
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 |
|---|---|---|
| FDG PET/MRAlso: FDG Positron Emission Tomography/Magnetic Resonance ScanParticipants will undergo a FDG, gadolinium enhanced PET/MR scan. | Procedure or surgery | Chemoradiation, Surgery |
Primary outcome
Proportion of patients who successfully complete PET/MR scans at all study time-points
Time frame: 2-3 months post-treatment
4 secondary outcomes
Sensitivity of PET/MR for baseline disease assessment
Time frame: pre-treatment
Specificity of hybrid PET/MR for baseline disease assessment
Time frame: pre-treatment
Accuracy of hybrid PET/MR for baseline disease assessment
Time frame: pre-treatment
Detection of disease with PET/MR at each time point
Time frame: pre-treatment to 2-3 months post-treatment
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 3 Dec 2021.
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Cervical Cancer
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Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
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Enrolling by invitationObservational study
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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.
Jorge Oldan, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervix Carcinoma and Cervical Squamous Cell Carcinoma, run by UNC Lineberger Comprehensive Cancer Center 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 7 inclusion and 10 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 3 Dec 2021. 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.
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?
Proportion of patients who successfully complete PET/MR scans at all study time-points (time frame: 2-3 months post-treatment). 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 3 Dec 2021.