FDG-PET for Cervical Cancer
(HPVDNA02 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University Health Network, Toronto
Must be taking: Cisplatin
Disqualifiers: Distant metastases, Other tumor histologies, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves standard care treatment with radiotherapy and chemotherapy, it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment 18F-FDG PET-CT for cervical cancer?
Research shows that 18F-FDG PET-CT is better than CT and MRI at detecting recurrent cervical cancer and assessing the extent of the disease, which can help in making more informed treatment decisions. Additionally, it has high prognostic value for predicting progression-free survival in patients with advanced cervical cancer, making it useful for clinical staging and treatment planning.
12345Is FDG-PET safe for use in humans?
FDG-PET, which is a type of imaging test, is generally considered safe for humans. It uses a small amount of radioactive material to help doctors see how tissues and organs are functioning, and it has been used in various types of cancer, including cervical cancer, without significant safety concerns.
26789How does FDG-PET differ from other treatments for cervical cancer?
FDG-PET is unique because it uses a special imaging technique to help manage cervical cancer by detecting cancerous cells through their glucose uptake, which can be particularly useful for staging and restaging the disease. Unlike traditional treatments that directly target the cancer, FDG-PET provides detailed images that can guide treatment decisions.
2691011Eligibility Criteria
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.Inclusion Criteria
My cervical cancer is confirmed and is at stage IB-IVA.
I am 18 years old or older.
I am scheduled for intense radiotherapy and chemotherapy with cisplatin.
Exclusion Criteria
My cancer has spread to distant parts of my body, but it may include certain lymph nodes if they can be targeted by radiation.
I have had cancer before, but it was either skin cancer or treated and clear for over 5 years.
I cannot undergo chemotherapy due to a health issue like kidney failure.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard of care treatment with chemotherapy and radiotherapy
6-8 weeks
Post-Treatment Assessment
FDG-PET Scan and blood tests for HPV DNA to detect leftover cervical cancer cells
3 months
1 visit (in-person)
Follow-up
Participants are monitored for progression-free survival and plasma HPV DNA levels
Up to 5 years
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University Health Network, The Princess MargaretToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
Sunnybrook Health Sciences CentreCollaborator
References
Correlation between tumor glucose metabolism and multiparametric functional MRI (IVIM and R2*) metrics in cervical carcinoma: Evidence from integrated 18 F-FDG PET/MR. [2020]Label="BACKGROUND">Multiparameter, multimodality 18 F-FDG PET/MRI holds great potential for the diagnosis of cervical cancer based on the correlation between tumor glucose metabolism and imaging parameters.
Contribution of whole-body 18FDG PET imaging in the management of cervical cancer. [2022]The objective of this study was to assess the contribution of [(18)F]fluoro-2-deoxy-D-glucose positron emission tomography ((18)FDG PET) imaging in the management of cervical cancer.
Clinical impact of 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-positron emission tomography (PET) on treatment choice in recurrent cancer of the cervix uteri. [2018]The superiority of positron emission tomography (PET) with 2-deoxy-2-[18F]fluoro-D-glucose (FDG) over computed tomography and magnetic resonance imaging in detecting recurrent cervical cancer and determining the extent of the disease has been demonstrated in several clinical trials. However, there is a lack of data concerning the clinical impact of the extra findings. We report here a prospective clinical study aimed at investigating the clinical impact of FDG-PET findings on the treatment plans in recurrent cervical cancer.
Prognostic value of 18F-FDG PET in uterine cervical cancer patients with stage IIICr allocated by imaging. [2023]The effect on survival of radiographic lymph node metastasis in uterine cervical cancer patients is more important than before, even though its prognostic value not been well investigated. The aim of our study is to evaluate the prognostic potential of 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET) compared with Computed Tomography (CT) in uterine cervical cancer patients with stage IIICr allocated by imaging. Fifty-five patients with biopsy-proven primary cervical cancer underwent definitive radiation therapy for stages IIB-IVB of The International Federation of Gynecology and Obstetrics (FIGO) 2018 classifications. The prognostic performance of pretreatment 18F-FDG PET and CT for assessing lymph node metastasis was evaluated by two experienced readers. The PET and CT findings were correlated with the risk of progression-free survival (PFS) and overall survival (OS). Kaplan-Meier survival curves showed that PFS was significantly worse in patients with positive lymph nodes on 18F-FDG PET than in those patients with negative lymph nodes on 18F-FDG PET (p = 0.003), whereas there was no significant difference in PFS between patients with lymph nodes sized ≥ 1 cm and those sized < 1 cm (p = 0.140). Univariate analysis showed that positive lymph nodes on 18F-FDG PET was significantly associated with poor PFS (p = 0.006), whereas lymph node size was not significantly associated with poor PFS (p = 0.145). In multivariate analysis, positive lymph nodes on 18F-FDG PET was significantly associated with poor PFS (p = 0.006) and was an independent prognostic factor for PFS. 18F-FDG PET offers high prognostic value for patients with stage IIICr allocated by imaging compared with CT, suggesting that 18F-FDG PET might be useful in clinical staging decisions and thus promote optimal diagnostic and therapeutic strategies.
Imaging uterine cervical cancer with FDG-PET/CT: direct comparison with PET. [2021]To compare 2-deoxy-2-[F-18]fluoro-D-glucose-positron emission tomography (FDG-PET) and PET/computed tomography (CT) for certainty of image interpretation and for diagnostic accuracy in patients with primary and metastatic uterine cervical cancer.
Evaluation of ¹⁸F-FDG PET/CT in early-stage cervical carcinoma. [2016]The purpose is to evaluate ¹⁸F-fluorodeoxy glucose-positron emission tomography (PET)/computed tomography (CT) for the detection of cervical carcinoma of the International Federation of Gynecology and Obstetrics stages Ib and IIa.
Pathway-specific analysis of gene expression data identifies the PI3K/Akt pathway as a novel therapeutic target in cervical cancer. [2022]Cervical tumor response on posttherapy 2[(18)F]fluoro-2-deoxy-d-glucose-positron emission tomography (FDG-PET) is predictive of survival outcome. The purpose of this study was to use gene expression profiling to identify pathways associated with tumor metabolic response.
The Role of FDG-PET/CT in Cervical Cancer: Diagnosis, Staging, Radiation Treatment Planning and Follow-Up. [2016]Routine screening has lead to significant improvement in the incidence and mortality of cervical cancer in industrialized nations. Current International Federation of Gynecologists and Obstetricians staging is based mainly on clinical examination, with anatomic conventional imaging modalities, such as CT and MR imaging, also being routinely used. Metabolic imaging using 18F-fluoro-2-deoxy-D-glucose(FDG)-PET provides highly specific, noninvasive pretreatment staging and prognostic information regarding post-therapy, and can detect asymptomatic, potentially curable locoregional recurrences. FDG-PET/CT can also optimize the use of advanced radiation treatment planning techniques, such as image-guided intensity modulated radiation therapy, for cervical cancer and may be of value in the development of additional novel approaches, such as stereotactic body radiation therapy.
Evaluation of FDG PET in patients with cervical cancer. [2016]Although many human cancers can be imaged by 2-[18F]-fluoro-2-deoxy-D-glucose (FDG) and PET, there is little clinical experience with FDG PET in cervical cancer. The purpose of this study was to evaluate the feasibility of FDG PET scans on patients with cervical cancer.
Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. [2016]The role of positron emission tomography (PET) with fluorine-18-labeled fluoro-2-deoxy-d-glucose (FDG) in cervical cancer has not yet been well defined. We conducted a prospective study to investigate its efficacy in comparison with magnetic resonance imaging and/or computed tomography (MRI-CT).
Restaging of recurrent cervical carcinoma with dual-phase [18F]fluoro-2-deoxy-D-glucose positron emission tomography. [2016]The clinical value of positron emission tomography (PET) with [18F]fluoro-2-deoxy-D-glucose (FDG) for primary staging in cervical carcinoma appears to be promising. The authors sought to evaluate the diagnostic efficacy and benefit of PET in restaging cervical carcinoma at the time of first recurrence.