Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer (LACC) Cervical Cancer

NCT03129776TerminatedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Sunnybrook Health Sciences Centre

Enrollment

4

Start Date

2017-11-13

Completion Date

2022-09-15

Study Type

INTERVENTIONAL

Official Title

Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer for Treatment With Definitive Chemoradiation Therapy

Interventions

Hyperpolarized 13C-Pyruvate18F-FDG

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, International Federation of Gynecology and Obstetrics (FIGO) stage IB-IVA
* Planned treatment with radical radiotherapy with or without concurrent cisplatin chemotherapy.
* Age ≥ 18 years.

Exclusion Criteria:

* Any anticancer treatment for their cervical cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Other cervical cancer tumor histologies (e.g. small cell, serous)
* Contraindications to 18FDG PET-CT
* Inability to lie supine for 18FDG PET-CT
* Contraindication to radiotherapy (e.g. severe Crohn's disease)
* History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
* Known pregnancy or lactating

Outcome Measures

Primary Outcomes

Time resolved, 3D 13C lactate images from subjects with cervical cancer.

Feasibility of acquiring time resolved, 3D 13C lactate images from subjects with cervical cancer.

Time frame: 1 year

Secondary Outcomes

Correlation of MRI and 18FDG-PET images

Visual analysis and correlation between images obtained following Hyperpolarized Pyruvate (13C) Injection and 18FDG-PET imaging to identify cervical cancer.

Time frame: 1 Year

Locations

Sunnybrook Health Sciences Centre, Toronto, Canada

Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer (LACC) Cervical Cancer