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PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219904
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Stage IA Cervical Cancer Stage IA1 Cervical Cancer Stage IA2 Cervical Cancer Stage IB Cervical Cancer Stage IB1 Cervical Cancer Stage IB2 Cervical Cancer Stage IB3 Cervical Cancer Other: Fludeoxyglucose F-18 Drug: Gadobutrol Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. 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:

I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Resectable Cervical Carcinoma With PET/MRI
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Other: Fludeoxyglucose F-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • Fludeoxyglucose (18F)
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079

Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • nuclear magnetic resonance imaging

Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assessing the Lymph node involvement by PET/MRI [ Time Frame: 3 years ]
    Will determine the relationship with pathology.

  2. Inter-observer variability of PET/MR [ Time Frame: 3 years ]
    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.

  3. Quantitative imaging parameters of the tumor [ Time Frame: 3 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Allergic reaction to gadolinium based contrast
  • Body weight of greater than 450 (181.4 kg)
  • Patients requiring general sedation
  • Extremely claustrophobic patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219904


Contacts
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Contact: Sanaz Javadi 713-563-7665 sanaz.javadi@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sanaz Javadi    713-563-7665      
Principal Investigator: Sanaz Javadi         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sanaz Javadi M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04219904    
Other Study ID Numbers: 2017-0066
NCI-2019-08255 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0066 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals