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NCT Number: NCT03853915

FDG-PET and Circulating HPV in Patients With Cervical Cancer Treated With Definitive Chemoradiation (II)

Nearly all cervical cancers are caused by the human papilloma virus (HPV), which can be detected in cancer tissue by laboratory tests. There is evidence that the virus can also be detected from a blood sample to monitor the effects of treatment. Previous studies have shown that a special test called 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET-CT) at 3 months after treatment may predict survival in cervical cancer.

The purpose of this study is to see how well the FDG-PET Scan and blood tests for HPV can detect leftover cervical cancer cells after treatment. This study is not a particular form of treatment and patients will receive standard of care treatment.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Cervical cancer is the 4th most common malignancy in women worldwide. A significant proportion of women with locally advanced cervical cancer are primarily managed with chemotherapy and radiotherapy which has improved the 5-year survival and disease-free survival; however both local and distant recurrences still remain to be challenges after treatment.

A prospective study has shown that metabolic response on post-therapy FDG-PET scan at 3 months to be predictive of progression-free and overall survival in patients with locally advanced cervical cancer. It may also predict patterns of failures for these patients.

HPV is recognized as a necessary cause of the vast majority of cervical cancer and HPV DNA has been detected in circulation from patients with cervical cancer and oropharyngeal cancer at diagnosis and at the time of relapse. Despite the promising potential of HPV DNA to monitor response and detect recurrence at an early stage, no study has evaluated serial HPV DNA and its association with PET response and survival.

We have recently reported preliminary data from a feasibility study (HPVDNA01) on 20 patients. Detectable HPV DNA at the end of cervical radiation therapy predated the clinical diagnosis of metastases and was associated with inferior progression-free survival. Also, 3 month plasma HPV DNA level was more accurate than 3-month FDG PET imaging in detecting leftover disease. This follow-up study aims to validate the clinical utility of plasma HPV DNA detection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
  • 3.1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
  • 3.1.3 Age ≥ 18 years.

Exclusion criteria

  • Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field)
  • Patients who have received any anticancer treatment for their cervical cancer.
  • Other cervical cancer tumor histologies (e.g. small cell, serous)
  • Contraindications to 18FDG PET-CT
  • Contraindication to radiotherapy (e.g. severe Crohn's disease)
  • Contraindication to chemotherapy (e.g. non-reversible renal failure)
  • 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

Treatment and study plan

[18-F]- FDG - PET

Diagnostic Test

[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.

Primary outcomes

  1. Progression-free survival rate

    Time frame: up to 5 years

    The progression-free survival rate of patients with and without detectable plasma HPV DNA post treatment

Secondary outcomes

  1. Plasma HPV DNA levels

    Time frame: Up to 3 months

    The accuracy of 3-month FDG-PET or 3-month HPV DNA for predicting relapse will be estimated.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Han, MD

CONTACT

[email protected]

416 946 4501 ext. 2919

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Sunnybrook Health Sciences Centre

Registry information

Acronym: HPVDNA02

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Feb 26, 2019
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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