Stage IA Cervical CancerEarly Phase 1NCT04219904
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
A Early Phase 1 study testing Fludeoxyglucose F-18, Gadobutrol and Magnetic Resonance Imaging in people with Stage IA Cervical Cancer and Stage IA1 Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Cervical Cancer, Stage IA1 Cervical Cancer, Stage IA2 Cervical Cancer
- What is being tested?
- Fludeoxyglucose F-18, Gadobutrol and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 30 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors > 4 cm
- No contraindications to MRI
- Patients undergoing surgical procedure at MD Anderson
- Suspected cervical cancer
Who cannot join
- Patients who have contraindication to MRI
- Glomerular filtration rate (GFR) < 30
- Pregnant patients
- Patients with history of previous radiation
- Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
- Patients with endometrial cancer extending to the cervix
Show all 10Show fewer
- Allergic reaction to gadolinium based contrast
- Body weight of greater than 450 (181.4 kg)
- Patients requiring general sedation
- Extremely claustrophobic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Resectable Cervical Carcinoma With PET/MRI
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess depth of cervical invasion with positron emission tomography/magnetic resonance imaging (PET/MRI) in patients with cervical cancer in clinical Federation of Gynecology and Obstetrics (FIGO) staging undergoing evaluation for surgical resection and correlate with pathology.
SECONDARY OBJECTIVES:
- To correlate lymph node involvement on PET/MRI with pathology. II. To assess the inter-observer variability in the interpretation of PET/MRI. III. To correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level dependent (BOLD), intravoxel incoherent motion (IVIM) analysis, apparent diffusion coefficient (ADC), diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake value (SUV) and the glucose metabolic rate (GMR) with lymphovascular space invasion (LVSI) and tumor grade on surgical pathology.
OUTLINE:
Patients receive fludeoxyglucose F-18 and gadobutrol intravenously (IV) over 1 minute and undergo PET/MRI over 90-120 minutes.
- Conditions
- Stage IA Cervical Cancer, Stage IA1 Cervical Cancer, Stage IA2 Cervical Cancer, Stage IB Cervical Cancer, Stage IB1 Cervical Cancer, Stage IB2 Cervical Cancer
- Being tested
- Fludeoxyglucose F-18, Gadobutrol, Magnetic Resonance Imaging, Positron Emission Tomography
- 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.
Fludeoxyglucose F-18Other
Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18
Given IV
GadobutrolDrug
Also called BAY86-4875, Gadavist, Gadograf, Gadovist
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI
Undergo PET/MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan
Undergo PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (PET/MRI) | Experimental | Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes. Receives: Other: Fludeoxyglucose F-18; Drug: Gadobutrol; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
Measured: 3 years
Secondary outcomes (3)
Assessing the Lymph node involvement by PET/MRI
Will determine the relationship with pathology.
Measured: 3 years
Inter-observer variability of PET/MR
A PET report for clinical use will be generated by a radiologist with appropriate training and credentialing to read PET images. A separate MRI report for clinical use will be generated by a radiologist with appropriate training and credentialing to read MRI. Subsequently, PET/MR images will be evaluated by two radiologists who have appropriate training to read both PET and MRI and 2 research reports will be generated. Inter-observer variability of PET/MRI will be calculated using Cohen's kappa coefficient.
Measured: 3 years
Quantitative imaging parameters of the tumor
Correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level-dependent (BOLD), apparent diffusion coefficient (ADC), IVIM analysis, diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), MTV, TLG, standardized uptake value (SUV) and GMR with LVSI and tumor grade on surgical pathology which serves as gold standard. Two-sample t-test or analysis of variance (ANOVA) will be used for comparing the group means between LVSI positive/negative groups and among tumor grades and types. Other statistical analysis will be carried out as appropriate.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start7 Sep 2018
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IA Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sanaz Javadi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219904
- Sponsor's protocol ID
- 2017-0066
- Other IDs
- NCI-2019-08255, 2017-0066, P30CA016672
- Status last verified
- May 2026
- First submitted
- 30 Dec 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resectable Cervical Carcinoma With PET/MRI
- ClinicalTrials.gov ID
- NCT04219904
- Acronym / sponsor ID
- 2017-0066
- Conditions
- Stage IA Cervical Cancer, Stage IA1 Cervical Cancer, Stage IA2 Cervical Cancer, Stage IB Cervical Cancer, Stage IB1 Cervical Cancer, Stage IB2 Cervical Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Jan 2020 (actual)
- 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 trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
Detailed description
PRIMARY OBJECTIVE:
- To assess depth of cervical invasion with positron emission tomography/magnetic resonance imaging (PET/MRI) in patients with cervical cancer in clinical Federation of Gynecology and Obstetrics (FIGO) staging undergoing evaluation for surgical resection and correlate with pathology.
SECONDARY OBJECTIVES:
- To correlate lymph node involvement on PET/MRI with pathology. II. To assess the inter-observer variability in the interpretation of PET/MRI. III. To correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level dependent (BOLD), intravoxel incoherent motion (IVIM) analysis, apparent diffusion coefficient (ADC), diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake value (SUV) and the glucose metabolic rate (GMR) with lymphovascular space invasion (LVSI) and tumor grade on surgical pathology.
OUTLINE:
Patients receive fludeoxyglucose F-18 and gadobutrol intravenously (IV) over 1 minute and undergo PET/MRI over 90-120 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (PET/MRI) | Experimental | Other: Fludeoxyglucose F-18, Drug: Gadobutrol, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors > 4 cm
- No contraindications to MRI
- Patients undergoing surgical procedure at MD Anderson
- Suspected cervical cancer
Key exclusion criteria (10 listed)
- Patients who have contraindication to MRI
- Glomerular filtration rate (GFR) < 30
- Pregnant patients
- Patients with history of previous radiation
- Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
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 |
|---|---|---|
| Fludeoxyglucose F-18Also: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18Given IV | Other | Diagnostic (PET/MRI) |
| GadobutrolAlso: BAY86-4875, Gadavist, Gadograf, GadovistGiven IV | Drug | Diagnostic (PET/MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRIUndergo PET/MRI | Procedure or surgery | Diagnostic (PET/MRI) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography ScanUndergo PET/MRI | Procedure or surgery | Diagnostic (PET/MRI) |
Primary outcome
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
Time frame: 3 years
Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
3 secondary outcomes
Assessing the Lymph node involvement by PET/MRI
Time frame: 3 years
Inter-observer variability of PET/MR
Time frame: 3 years
Quantitative imaging parameters of the tumor
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Sanaz Javadi principal investigator
M.D. Anderson Cancer Center
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 Fludeoxyglucose F-18, Gadobutrol and Magnetic Resonance Imaging in people with Stage IA Cervical Cancer and Stage IA1 Cervical Cancer, run by M.D. Anderson 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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI) (time frame: 3 years). 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 20 May 2026.