Recruiting

Chemoradiation

Sponsor:

University Health Network, Toronto

Code:

NCT03853915

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18-F]- FDG - PET

Study Details

Brief summary:

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.

Conditions

Cervical Cancer

Study ID

NCT03853915

Start date

Apr 23, 2019

Status verified date

Mar, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: FDG PET Scan

\[F-18\] - FDG PET Scan and blood sample to measure HPV DNA

Interventions

[18-F]- FDG - PET

\[F-18\]-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 outcome measure

  • Progression-free survival rate [ Time Frame: up to 5 years ]

Central Contacts and Locations

Central contacts

Kathy Han, MD

416 946 4501kathy.han@rmp.uhn.ca

Locations

University Health Network, The Princess Margaret

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Kathy Han, MD

416 946 4501Kathy.Han@rmp.uhn.on.ca

Michael Milosevic, MD

416 946 4501Mike.Milosevic@rmp.uhn.on.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Cervical Cancer
  • PET Scan
  • HPV DNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.