MR Metabolic Biomarkers for Cervical Cancer

NCT ID: NCT01874548

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

Brief Summary

The purposes of this study are: (1) to develop magnetic resonance (MR) imaging and spectroscopy as surrogate biomarkers for altered cancer metabolism in cervical cancer; (2) to understand the function of human papillomavirus (HPV) infection and autophagy (a cellular catabolic degradation response to stress) in the metabolic alterations in cervical cancer.

Detailed Description

In the first part of this project, we aim to identify the differences in cancer metabolism between normal and cervical cancer. Conventional MR study plus magnetic resonance spectroscopy (MRS) and diffusion weighted imaging (DWI) sequences will be carried out on 30 eligible surgical candidates for pretreatment clinical assessment. Metabolites in cancer tissue will be collected during operation and analyzed using high resolution MRS, and compared with control group comprising 30 patients with normal cervical tissue. The primary endpoint of this part is to identify different MRS profiles between normal and cancer subjects. We will investigate the underlying biological mechanism between these two groups by evaluating status of HPV infection and autophagy. In the second part, we aim to understand cancer metabolism in cervical cancers infected by different types of HPV. We plan to enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis. The primary endpoint of this part is to compare MRS profiles from cancer tissue infected with different HPV genotypes, particularly HPV type 16 and HPV type 18. The secondary endpoint is to correlate the tissue MRS profiles with the in vivo MRS/DWI measured by clinical MR scanner. In the third part of this project, we aim to investigate cancer metabolism under combined chemoradiation therapy (CCRT). We plan to enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high-resolution MRS. Tissue MRS profiles will be correlated with the HPV, E6/E7 and autophagy.

The advance in knowledge of this project is to unwire the complex relationship among cancer metabolism, HPV infection and autophagy in cervical cancer. The clinical impact is the development of MR biomarkers for cancer metabolism and autophagy, both play important roles in the resistance to cancer therapy. The inherited non-invasiveness and non-radiation nature makes MR technique an ideal platform for clinical usage.

Conditions

Uterine Cervical Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal cervix

Control group (n=30) comprising surgical candidates with normal cervical tissue will be collected for comparison.

No interventions assigned to this group

Cervical cancer

1. 1st year: 30 surgical candidates with cervical cancer tissue collected during operation.

2. 2nd year: Enroll another 30 surgical candidates and complete the data regarding clinical MRS/DWI and tissue high resolution MRS. Together with the 30 cancer subjects in part one there will be in total 60 cancer subjects for analysis.

3. 3rd year: enroll 60 patients primarily treated with CCRT and collect the data using clinical MR and tissue high resolution MRS.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• be able to give informed consent.
• female patients between 20 and 80 years of age.
• biopsy proven newly diagnosed cervical cancer clinical stage International Federation of Gynecology and Obstetrics (FIGO) Ib and above.
• patients must be willing to undergo standard treatment such as surgery or chemo-radiation therapy.

Exclusion Criteria

• patients who are judged to be noncompliant to treatment or not accessible for follow up.
• patients with contraindications to magnetic resonance imaging (MRI) scanning, such as claustrophobia, cardiac pacemaker, metal implants in field of view, or unable to cooperate for MRI study due to mental status.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gigin Lin

Department of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gigin Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital

Locations

Department of Radiology, Chang Gung Memorial Hospital

Guishan, Taoyuan, Taiwan

Countries

Taiwan

References

Lin G, Lai CH, Tsai SY, Lin YC, Huang YT, Wu RC, Yang LY, Lu HY, Chao A, Wang CC, Ng KK, Ng SH, Chou HH, Yen TC, Hung JH. 1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes. J Magn Reson Imaging. 2017 Mar;45(3):899-907. doi: 10.1002/jmri.25386. Epub 2016 Jul 19.

Reference Type: BACKGROUND

PMID: 27434095 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/27434095

1 H MR spectroscopy in cervical carcinoma using external phase array body coil at 3.0 Tesla: Prediction of poor prognostic human papillomavirus genotypes.

Other Identifiers

102-0620A3

Identifier Type: -

Identifier Source: org_study_id