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FDG-PET for Cervical Cancer (HPVDNA02 Trial)

N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA
Age ≥ 18 years.
Must not have
Contraindication to chemotherapy (e.g. non-reversible renal failure)
Other cervical cancer tumor histologies (e.g. small cell, serous)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how well the FDG-PET scan and blood tests for HPV can detect leftover cervical cancer cells after treatment.

Who is the study for?
This trial is for adults over 18 with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous) at stages IB-IVA who are about to start standard treatment with radiotherapy and cisplatin chemotherapy. It's not open to those who've had previous cancer treatments, are pregnant or breastfeeding, have conditions that rule out PET-CT scans or radiotherapy like severe Crohn's disease, non-reversible kidney issues, other invasive cancers within the last 5 years (except certain skin cancers), or evidence of distant metastases.
What is being tested?
The study tests how well an FDG-PET Scan and blood tests for HPV can detect remaining cervical cancer cells after standard treatment. The FDG-PET Scan is a special imaging test that shows active areas of cancer by tracking a sugar molecule in the body. Blood tests will check for HPV presence as an indicator of treatment effectiveness.
What are the potential side effects?
Since this study involves diagnostic procedures rather than new treatments, side effects may include discomfort from the PET-CT scan process such as reactions to contrast materials used during imaging. There might also be typical risks associated with drawing blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cervical cancer is confirmed and is at stage IB-IVA.
Select...
I am 18 years old or older.
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I am scheduled for intense radiotherapy and chemotherapy with cisplatin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo chemotherapy due to a health issue like kidney failure.
Select...
My cervical cancer is not the usual type.
Select...
I have received treatment for my cervical cancer.
Select...
I cannot undergo radiotherapy due to a severe condition like Crohn's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival rate
Secondary study objectives
Plasma HPV DNA levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FDG PET ScanExperimental Treatment1 Intervention
\[F-18\] - FDG PET Scan and blood sample to measure HPV DNA

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
674 Previous Clinical Trials
1,565,425 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,274 Total Patients Enrolled

Media Library

[18-F]- FDG - PET Clinical Trial Eligibility Overview. Trial Name: NCT03853915 — N/A
Cervical Cancer Research Study Groups: FDG PET Scan
Cervical Cancer Clinical Trial 2023: [18-F]- FDG - PET Highlights & Side Effects. Trial Name: NCT03853915 — N/A
[18-F]- FDG - PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT03853915 — N/A
~17 spots leftby Dec 2026
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