Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Anti-Infective Agents

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.

Fludeoxyglucose F-18

Gadobutrol

Magnetic Resonance Imaging

Positron Emission Tomography

Sanaz Javadi

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.

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.

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

Evaluation of Resectable Cervical Carcinoma With PET/MRI

Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.

Will determine the relationship with pathology.

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.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer	NCT04219904	Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi...	Fludeoxyglucose... Gadobutrol Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer	NCT04219904	Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi...	Fludeoxyglucose... Gadobutrol Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer	NCT04219904	Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi...	Fludeoxyglucose... Gadobutrol Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer	NCT04219904	Stage IA Cervic... Stage IA1 Cervi... Stage IA2 Cervi... Stage IB Cervic... Stage IB1 Cervi... Stage IB2 Cervi... Stage IB3 Cervi...	Fludeoxyglucose... Gadobutrol Magnetic Resona... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage ib3 cervical cancer