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

Stage IB Cervical Cancer Clinical Trial

Official title:

Evaluation of Resectable Cervical Carcinoma With PET/MRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04219904
• Other study ID #: 2017-0066
• Secondary ID: NCI-2019-0825520
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 7, 2018
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Uterine Cervical Neoplasms

Intervention

Other:
• Fludeoxyglucose F-18
Given IV

Drug:
• Gadobutrol
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo PET/MRI
• Positron Emission Tomography
Undergo PET/MRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	Assessing the Lymph node involvement by PET/MRI	Will determine the relationship with pathology.	3 years
Secondary	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.	3 years
Secondary	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.	3 years

External Links

•   MD Anderson Cancer Center Website