FDG-PET for Cervical Cancer

(HPVDNA02 Trial)

Overseen By Kathy Han, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: Cisplatin

Disqualifiers: Distant metastases, Other tumor histologies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6-8 weeks

64 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{2 6 7 8 9}

How 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. ^{2 6 9 10 11}

Eligibility 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.

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

Treatment Details

Interventions

• [18-F]- FDG - PET

Trial Overview 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.

Participant Groups

Group I: FDG PET Scan Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Findings from Research

In a study of 54 patients with cervical carcinoma, the hybrid 18F-FDG PET/MRI technique demonstrated a significant correlation between tumor glucose metabolism (measured by SUVmax and SUVmean) and various functional MRI metrics, indicating its potential for assessing tumor heterogeneity.

The study found that specific MRI parameters (R2*, f, and D) can provide insights into the tumor's hypoxic conditions and blood perfusion, suggesting that this multimodal imaging approach could enhance the understanding and diagnosis of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between tumor glucose metabolism and multiparametric functional MRI (IVIM and R2*) metrics in cervical carcinoma: Evidence from integrated 18 F-FDG PET/MR. Li-Ou, Z., Hong-Zan, S., Xiao-Xi, B., et al.[2020]

In a study of 60 cervical cancer patients, (18)FDG PET imaging was found to be effective in detecting extrapelvic metastases, identifying 9 unsuspected nodal sites that MRI missed, which influenced treatment decisions in 18% of cases.

While PET was superior in diagnosing recurrent disease in patients with negative or unclear conventional imaging, MRI remained more effective for assessing the local spread of the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of whole-body 18FDG PET imaging in the management of cervical cancer. Belhocine, T., Thille, A., Fridman, V., et al.[2022]

In a study of 36 patients with suspected recurrent cervical cancer, FDG-PET imaging detected more metastatic sites in 56% of cases compared to conventional imaging methods, highlighting its superior diagnostic capability.

FDG-PET results significantly influenced treatment plans, leading to changes in treatment modality for 33% of patients and a shift from curative to palliative intent in 30% of cases, demonstrating its critical role in clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bjurberg, M., Brun, E.[2018]

In a study of 55 patients with stage IIICr cervical cancer, 18F-FDG PET imaging was found to be a significant prognostic tool, indicating that positive lymph node metastasis detected by PET is associated with worse progression-free survival (PFS).

Unlike lymph node size, which did not show a significant correlation with PFS, the presence of positive lymph nodes on 18F-FDG PET was identified as an independent prognostic factor, suggesting that PET could enhance clinical staging and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of 18F-FDG PET in uterine cervical cancer patients with stage IIICr allocated by imaging. Isaji, Y., Tsuyoshi, H., Tsujikawa, T., et al.[2023]

In a study of 13 patients with cervical cancer, PET/CT imaging significantly improved the localization and characterization of cancer lesions compared to PET alone, with over 30% and 20% higher rates of definite findings, respectively.

PET/CT demonstrated higher diagnostic accuracy for identifying lesions (92% accuracy) compared to PET (78% accuracy), making it a more effective tool for evaluating cervical cancer, although both methods were similarly effective in assessing metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging uterine cervical cancer with FDG-PET/CT: direct comparison with PET. Tatsumi, M., Cohade, C., Bristow, RE., et al.[2021]

In a study of 22 patients with early-stage cervical carcinoma, ¹⁸F-fluorodeoxy glucose-PET/CT demonstrated a high accuracy of 95.45% for detecting the cancer, with 20 out of 22 patients showing abnormal uptake.

The imaging technique also had a low false-negative rate of 6.25% for predicting pelvic nodal involvement, indicating it is a reliable method for assessing the spread of early-stage cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of ¹⁸F-FDG PET/CT in early-stage cervical carcinoma. Yu, L., Jia, C., Wang, X., et al.[2016]

In a study of 62 patients with advanced cervical cancer, those who achieved a complete metabolic response on FDG-PET after treatment had a significantly higher 3-year survival rate of 98%, compared to only 39% for those with an incomplete response.

Gene expression profiling revealed that activation of the PI3K/Akt signaling pathway is linked to poor metabolic response, suggesting that targeting this pathway with inhibitors like LY294002 could enhance treatment effectiveness in cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathway-specific analysis of gene expression data identifies the PI3K/Akt pathway as a novel therapeutic target in cervical cancer. Schwarz, JK., Payton, JE., Rashmi, R., et al.[2022]

Routine screening has significantly reduced cervical cancer incidence and mortality in industrialized countries, highlighting the importance of early detection.

Metabolic imaging with FDG-PET/CT offers precise, noninvasive staging and prognostic insights for cervical cancer, improving treatment planning and potentially identifying curable recurrences that traditional imaging may miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of FDG-PET/CT in Cervical Cancer: Diagnosis, Staging, Radiation Treatment Planning and Follow-Up. Haynes-Outlaw, ED., Grigsby, PW.[2016]

FDG PET scans were successfully performed on 21 patients with cervical cancer, detecting 76% of newly diagnosed or recurrent cases, indicating its feasibility and potential effectiveness in identifying these cancers.

The use of postvoid imaging significantly improved the detection rate, allowing for 100% detection of cancers in patients scanned this way, and FDG PET was more effective than CT in identifying lymph node metastases, detecting 86% compared to CT's 57%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of FDG PET in patients with cervical cancer. Sugawara, Y., Eisbruch, A., Kosuda, S., et al.[2016]

In a study of 135 patients with locally advanced or recurrent cervical cancer, dual-phase FDG-PET was found to be significantly more effective than MRI-CT in identifying metastatic lesions, with an area under the curve (AUC) of 0.951 compared to 0.879 for MRI-CT.

The dual-phase FDG-PET not only improved detection rates of metastatic lesions (90% vs. 70% for conventional PET) but also influenced treatment decisions for 31% of patients, indicating its potential to enhance clinical management of cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. Yen, TC., Ng, KK., Ma, SY., et al.[2016]

In a study of 40 patients with recurrent cervical carcinoma, dual-phase FDG-PET was found to be significantly more effective than CT/MRI in identifying metastatic lesions, with a sensitivity of 92% compared to 60%.

Restaging with PET led to treatment modifications in 55% of patients and was associated with a significantly better 2-year overall survival rate for those who underwent primary surgery, highlighting its clinical value in optimizing management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restaging of recurrent cervical carcinoma with dual-phase [18F]fluoro-2-deoxy-D-glucose positron emission tomography. Lai, CH., Huang, KG., See, LC., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Contribution of whole-body 18FDG PET imaging in the management of cervical cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Prognostic value of 18F-FDG PET in uterine cervical cancer patients with stage IIICr allocated by imaging. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Imaging uterine cervical cancer with FDG-PET/CT: direct comparison with PET. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of ¹⁸F-FDG PET/CT in early-stage cervical carcinoma. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Pathway-specific analysis of gene expression data identifies the PI3K/Akt pathway as a novel therapeutic target in cervical cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Role of FDG-PET/CT in Cervical Cancer: Diagnosis, Staging, Radiation Treatment Planning and Follow-Up. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of FDG PET in patients with cervical cancer. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Value of dual-phase 2-fluoro-2-deoxy-d-glucose positron emission tomography in cervical cancer. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Restaging of recurrent cervical carcinoma with dual-phase [18F]fluoro-2-deoxy-D-glucose positron emission tomography. [2016]