Clinical trial NCT04219904: PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
Official title: Evaluation of Resectable Cervical Carcinoma With PET/MRI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
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
Stage IB3 Cervical Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-07
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
timeFrame: 3 years
Secondary outcomes:
measure: Assessing the Lymph node involvement by PET/MRI
timeFrame: 3 years
measure: Inter-observer variability of PET/MR
timeFrame: 3 years
measure: Quantitative imaging parameters of the tumor
timeFrame: 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sanaz Javadi
role: PRINCIPAL_INVESTIGATOR
References: