PET Imaging with 18F-FDG for Cervical Cancer

Not currently recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Renal insufficiency, Uncontrolled hypertension, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special imaging technique can better identify cancerous lymph nodes in the pelvis of women with certain types of cervical or endometrial cancer. By using a radioactive substance called 18F-Fluorodeoxyglucose (18F-FDG) during a PET/CT or PET/MRI scan, researchers aim to see cancer more clearly before surgery. Women diagnosed with stage IB1 cervical cancer or certain high-grade endometrial cancers who are planning for surgery might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative imaging technique.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for cervical cancer patients?

Research has shown that 18F-Fluorodeoxyglucose (18F-FDG) is often used in PET scans to help detect cancer in the body. Studies have found it useful for determining the stage of cervical cancer and planning treatment. This helps doctors understand the extent of cancer spread and decide on the best treatment plan.

Regarding safety, 18F-FDG is generally well-tolerated. Although it is a radioactive substance, only small amounts are used during scans. No specific evidence from these studies indicates negative side effects when injected into the cervix. However, since this study is in its early phase, it primarily focuses on safety, and any risks are closely monitored.

In conclusion, while 18F-FDG is widely used and considered safe for imaging, this trial takes extra precautions to ensure its safety when injected into the cervix for cervical cancer imaging. Participants will be closely monitored for any adverse reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-Fluorodeoxyglucose (18F-FDG) in combination with PET/CT and PET/MRI imaging for cervical cancer because it offers a unique approach to detecting cancerous tissues. Unlike traditional imaging methods, which might not clearly distinguish between healthy and cancerous cells, 18F-FDG highlights cancer cells by targeting their higher glucose uptake, making them stand out more vividly during scans. This targeted approach could potentially lead to more precise staging and treatment planning, allowing doctors to tailor interventions more effectively. Additionally, using advanced imaging techniques like PET/MRI can provide more detailed information about the tumor's structure and activity, which could improve surgical outcomes and overall patient management.

What evidence suggests that PET imaging with 18F-FDG is effective for cervical cancer?

This trial will evaluate the effectiveness of 18F-FDG PET/CT and PET/MRI imaging for cervical cancer. Studies have shown that 18F-FDG PET/CT scans effectively detect cervical cancer, especially in identifying cancer in the lymph nodes near the cervix and uterus. One study found these scans to be 88.7% accurate in predicting primary cervical cancer, with a high ability to both detect cancer and confirm its absence. PET/MRI scans also demonstrate high accuracy and surpass MRI alone in assessing cancer spread. Both types of scans help predict patient response to treatment, making them valuable tools in managing cervical cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Jennifer Mueller, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with stage IB1 cervical cancer or high-grade endometrial cancer, who are fit for surgery and have controlled blood pressure. They must not be pregnant, have a hemoglobin level of at least 10 g/dL, albumin of at least 3 g/dL, glucose under 200 mg/dL, creatinine under 1.6 mg/dL, and no severe health conditions that would interfere with an MRI.

Inclusion Criteria

I am a woman with early-stage cervical cancer eligible for surgery.

I have stage I high-grade endometrial cancer and plan to have surgery.

My endometrial cancer is early stage but aggressive, shown by MRI or high CA-125 levels.

Exclusion Criteria

Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI

I cannot have an MRI due to a medical condition or device, or because I can't lie flat.

Plasma glucose >200 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Imaging

Participants undergo intracervical 18F-FDG injection during a dynamic PET/CT scan to map lymph nodes before surgery

1 day

1 visit (in-person)

Surgery and Standard Care

Participants receive standard peri- and postoperative care following the imaging procedure

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluorodeoxyglucose (18F-FDG)
• PET/CT imaging
• PET/MRI imaging

Trial Overview

The study tests if injecting a radioactive substance called 18F-FDG into the cervix before surgery can better identify which pelvic lymph nodes contain cancer using PET/CT or PET/MRI imaging techniques.

How Is the Trial Designed?

Group I: intracervical 18F-FDG injection during a dynamic PET/CT Experimental Treatment 3 Interventions

The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

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]

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 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 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]

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 ...

Conclusion. This study demonstrates favorable efficacy of 18F-FDG PET/CT for identification of residual/recurrent cervical cancer, as well as for localization ...

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.

insightsimaging.springeropen.com

insightsimaging.springeropen.com/articles/10.1186/s13244-023-01589-1

Diagnostic accuracy of MRI, CT, and [ 18 F]FDG-PET-CT in ...

In conclusion, [18F]FDG-PET-CT outperformed MRI and CT in detecting nodal metastases in patients with early-stage cervical cancer with a ...

4.

mdpi.com

mdpi.com/2077-0383/13/23/7445

Assessing the Efficacy of 18F FDG PET-CT in Preoperative ...

This study found that 18F FDG PET-CT had an overall accuracy of 88.7% in predicting primary cervical cancer, followed by a sensitivity of 86.8% and specificity ...

5.

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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8338789/

Standardized Uptake Value for 18F-Fluorodeoxyglucose is ...

Chemo-radiotherapy for locally advanced cervical cancer fails in over a third of patients. Biomarkers with therapeutic implications are therefore needed.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1048891X24087541

Prognostic Value of Pretreatment 18F-fluorodeoxyglucose ...

In the present study, we analyzed the FDG uptake of cervical tumors using the SUVmax value and evaluated whether FDG uptake can predict survival outcome in ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6658597/

Prognostic value of post-treatment 18F-fluorodeoxyglucose ...

The present study demonstrated that response evaluation using post-RT 18F-FDG PET could be a strong prognostic factor for both OS and PFS in uterine cervical ...

9.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12232-7

[18F]FDG-PET/CT-based risk stratification in women with ...

[18F]FDG-PET/CT is used for staging and treatment planning in patients with locally advanced cervical cancer (LACC).