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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how effectively a special scan, FDG-PET (Fluorodeoxyglucose Positron Emission Tomography), and blood tests can detect residual cervical cancer cells after treatment. The focus is on cervical cancer associated with the human papilloma virus (HPV). Participants will receive only standard care, without any new treatments. This trial suits individuals with cervical cancer who are scheduled for radiation and chemotherapy. As an unphased trial, it allows participants to contribute to research that may enhance future diagnostic methods.

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 prior data suggests that the FDG-PET scan is safe for detecting cervical cancer cells?

Research has shown that the FDG PET scan can help predict survival in cervical cancer patients. This imaging method often checks treatment effectiveness. Studies have found FDG PET scans useful in detecting any remaining cancer cells.

Regarding safety, this imaging technique is generally well-tolerated. It doesn't require surgery or invasive procedures, using only a small amount of radioactive material to create images of the body's interior. Studies have not reported any major safety concerns, suggesting it is a safe option for patients needing follow-up after cervical cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the [F-18] FDG PET scan for cervical cancer because it offers a way to visualize cancer cells in the body more precisely than traditional imaging methods. Unlike standard treatments that primarily rely on surgery, chemotherapy, or radiation, this approach uses a radioactive glucose compound to highlight cancerous areas, potentially detecting cancer earlier and more accurately. Additionally, by measuring HPV DNA from blood samples, this technique could provide insights into the cancer’s progression and response to treatment, offering a comprehensive view that current methods might miss.

What evidence suggests that the FDG-PET scan is effective for detecting leftover cervical cancer cells?

Research has shown that the 18F-FDG PET/CT scan, which participants in this trial will undergo, helps assess cervical cancer. Studies indicate it can predict patient survival. The scan measures the absorption of a special sugar (FDG) by cells, revealing cancer activity. High absorption often indicates more active cancer, while low absorption may suggest less activity. This makes it a useful tool for evaluating patient response to treatment. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4157596/

Efficacy of 18F-FDG PET/CT in the evaluation of patients ... Overall, these findings further show that PET/CT is very useful for the evaluation of recurrent cervical cancer, both on a per-patient and per-lesion analysis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24019480

Prognostic Value of Fluorine-18-Fluorodeoxyglucose ... Uptake of 18F-FDG on PET or PET/CT either before or after treatment has a promising value of both predicting survival outcomes for patients with cervical cancer ...

3. nature.com nature.com/articles/s41598-023-46261-2

Prognostic value of 18F-FDG PET in uterine cervical ... 18 F-FDG PET offers high prognostic value for patients with stage IIICr allocated by imaging compared with CT, suggesting that 18 F-FDG PET might be useful in ...

4. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=232

Positron Emission Tomography (FDG) for Cervical Cancer CMS agrees and proposes that there is no credible evidence that the results of FDG PET imaging are useful to make the initial diagnosis of cervical cancer, and ...

5. ejgo.org ejgo.org/DOIx.php?id=10.3802/jgo.2021.32.e74

Long-term outcomes of cervical cancer patients with ... We found that advanced stage and higher TLGp values were significant predictors for poor survival and higher progression rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11119194/

Impact of PET/CT Imaging with FDG in Locally Advanced ... FDG-PET has low efficacy in screening and is considered as not appropriate for imaging early-stage cervical cancer. Diagnostic imaging plays a modest role in ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/209517

Association of Posttherapy Positron Emission Tomography ... In this single-site study population of women with cervical cancer, 3-month posttherapy FDG uptake, as detected by whole-body PET, was predictive of survival.