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NCT Number: NCT04219904

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stage IA Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Stage IA1 Cervical Cancer Stage IA2 Cervical Cancer Stage IB Cervical Cancer Stage IB1 Cervical Cancer Stage IB2 Cervical Cancer Stage IB3 Cervical Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludeoxyglucose F-18

Other

Given IV

Other names: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Gadobutrol

Drug

Given IV

Other names: BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079

Magnetic Resonance Imaging

Procedure

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

Positron Emission Tomography

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Evaluation of Resectable Cervical Carcinoma With PET/MRI

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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