FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers

Overseen By Eileen Duffy, RN BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Disqualifiers: No visible disease, Breastfeeding, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using PET scans (specifically FDG PET scans) to guide radiation therapy for certain gastrointestinal and gynecologic cancers. The goal is to determine if early PET scans during treatment can help doctors adjust radiation plans for better outcomes. It focuses on cancers such as cervical, vulvar, esophageal, and anal canal cancer. Individuals diagnosed with these cancers and having visible tumors on imaging might be suitable candidates. The study aims to improve treatment by closely monitoring how cancer responds to radiation early in the process. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Will I have to stop taking my current medications?

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 protocol is safe for gastrointestinal and gynecologic cancers?

Research has shown that FDG-PET scans, like those used in this trial, are generally easy for patients to handle. These scans often help determine the extent of cancer spread and assess treatment effectiveness. Although specific safety details for this trial are unavailable, FDG-PET has been safely used in other studies involving stomach and female reproductive system cancers.

Other research has reported no major safety issues. The scans allow doctors to monitor cancer response without harming patients. Since this trial is in phase 2, the treatment has already passed initial safety tests, suggesting that FDG-PET scans are safe for further study in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using FDG-PET scans to guide radiation for gastrointestinal and gynecologic cancers because this technique allows for more precise targeting of tumors. Unlike traditional methods that rely on anatomical imaging, FDG-PET scans visualize metabolic activity, helping doctors identify the most active cancer cells. This approach could lead to more effective radiation therapy with potentially fewer side effects, as it aims to spare healthy tissue by honing in on the cancerous areas more accurately. Overall, the hope is to improve outcomes and quality of life for patients undergoing radiation treatment.

What evidence suggests that this protocol is effective for gastrointestinal and gynecologic cancers?

This trial will use FDG-PET scans to guide radiation therapy for gastrointestinal and gynecologic cancers. Studies have shown that combining FDG-PET scans with radiation therapy can significantly enhance treatment effectiveness. For instance, cancer patients with a clear FDG-PET scan post-treatment had an 86% chance of remaining cancer-free for two years, compared to only 40% for those with persistent signs of cancer. Additionally, FDG-PET/CT scans have improved the detection rate of gynecological cancers from 37.6% to 69.4%, while maintaining high accuracy in confirming cancer presence. This means it can more reliably identify cancer and reduce false positives. These findings suggest that using FDG-PET scans in planning radiation therapy could improve treatment outcomes for cancers of the digestive system and female reproductive organs. ^{1 3 6 7 8}

Who Is on the Research Team?

Junzo Chino, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of cancer (cervical, vulvar, esophageal, anal) who are not pregnant or breastfeeding. They must have a performance status indicating they can carry out daily activities with ease or with some limitation and visible disease on imaging before radiotherapy.

Inclusion Criteria

My cancer diagnosis is confirmed for cervical, vulvar, esophageal, or anal canal.

I can take care of myself and am up and about more than 50% of my waking hours.

I have signed or will sign the consent form for this study.

Exclusion Criteria

Breastfeeding

Positive serum pregnancy test

No gross disease visible on imaging at the start of radiotherapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy with adaptive PET-CT planning to evaluate and potentially adjust treatment plans

3-5 weeks

2 research PET scans, multiple radiation therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular follow-up imaging and evaluations

4 years

What Are the Treatments Tested in This Trial?

Interventions

• FDG PET scan

Trial Overview The study tests if PET scans during radiation therapy can help adapt the treatment plan to improve outcomes for patients with specific gastrointestinal and gynecologic cancers. It builds upon previous research suggesting benefits of intra-treatment PET imaging.

How Is the Trial Designed?

Group I: Single arm interventional study Experimental Treatment 1 Intervention

Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

FDG-PET is a valuable tool for assessing locally advanced gastrointestinal cancers and for detecting recurrences, enhancing diagnostic accuracy when combined with CT imaging.

The use of FDG-PET is expanding to include treatment response evaluation and prognosis prediction, with ongoing development of new PET probes aimed at personalizing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography for the diagnosis and management of patients with gastrointestinal malignancies. Saga, T., Nakamoto, Y., Higashi, T., et al.[2016]

PET/CT imaging, particularly with the radiotracer 18F-FDG, is crucial in managing gastrointestinal cancers, but its variable uptake in the bowel can complicate interpretations, especially in the presence of benign conditions that mimic malignancies.

Awareness of common patterns of radiotracer biodistribution and potential artifacts is essential for accurate diagnosis, as certain benign conditions and post-treatment changes can lead to intense uptake that may obscure true malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variants and Pitfalls in PET/CT Imaging of Gastrointestinal Cancers. Jayaprakasam, VS., Paroder, V., Schöder, H.[2023]

Fluorine-18-fluorodeoxyglucose (FDG)-PET/CT is recommended for baseline assessment in cervical cancer and for staging in vulvar and vaginal cancers, highlighting its importance in the initial evaluation of these gynecologic malignancies.

FDG-PET/CT is also valuable in planning definitive and salvage radiation treatments for recurrent gynecologic cancers, and it has supportive data for use in posttreatment evaluations, particularly for cervical and vulvar cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of PET Imaging in Gynecologic Radiation Oncology. Rao, YJ., Grigsby, PW.[2018]

Using PET scans with the glucose analog [18F]-FDG can effectively monitor how well tumors respond to chemotherapy and chemoradiotherapy, particularly in gastrointestinal cancers.

FDG PET can help differentiate between remaining tumor tissue and therapy-induced fibrosis, and it may predict patient outcomes early in treatment, allowing for timely adjustments in therapy for nonresponders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy Monitoring with Fluorine-18 FDG-PET and Fluorine-18 FDG-PET/CT. Wieder, HA., Herrmann, K.[2016]

FDG-PET/CT is an effective imaging technique for staging, assessing treatment response, and diagnosing recurrent cervical and ovarian cancers.

The potential applications of FDG-PET/CT in other gynecologic cancers, such as endometrial cancer and uterine sarcomas, remain under-researched, indicating a need for further exploration in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET/CT Imaging in Gynecologic Malignancies Other than Ovarian and Cervical Cancer. Bhosale, P., Iyer, R., Jhingran, A., et al.[2016]

In a study of 46 patients undergoing immunotherapy for various cancers, 61% developed immune-related adverse events (irAEs) detectable by 18F-FDG PET/CT, highlighting its importance in monitoring treatment effects.

The most common irAE detected was enteritis/colitis, occurring in 28.2% of patients, indicating that PET/CT can effectively identify significant inflammatory responses associated with immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. Tatar, G., Alçin, G., Sengul Samanci, N., et al.[2022]

FDG-PET scanning is a highly effective diagnostic tool for gastrointestinal cancers, particularly in staging oesophageal carcinoma and detecting recurrence in colorectal carcinoma, with sensitivity rates reaching up to 100%.

The technique is also valuable for differentiating between benign and malignant pancreatic lesions, showing high sensitivity and specificity, making it a crucial part of cancer diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDG-PET scanning in the diagnosis of gastrointestinal cancers. van Kouwen, MC., Oyen, WJ., Nagengast, FM., et al.[2019]

FDG-PET is a valuable imaging technique for staging and monitoring gastrointestinal tumors, particularly effective in detecting distant metastases in esophageal and gastric cancer, which can prevent unnecessary surgeries.

It is also useful for assessing therapy responses in rectal carcinoma and monitoring other gastrointestinal cancers, although it has limitations in lymph node staging and is not sufficient for certain liver cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[[18F]-FDG-PET in the diagnostics of gastrointestinal tumors]. Buchmann, I., Ganten, TM., Haberkorn, U.[2016]

18F-Fluorodeoxyglucose PET/CT imaging is crucial for assessing cancer treatment, including staging and monitoring responses, especially in patients undergoing immunotherapy.

The review highlights the importance of recognizing immune-related adverse events (irAEs) that can appear on imaging, as early detection is vital for effective management and to avoid misinterpreting treatment effects as disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy-related adverse effects on 18F-FDG PET/CT imaging. Gandy, N., Arshad, MA., Wallitt, KL., et al.[2021]

Incorporating 18F-FDG PET CT in radiotherapy planning for gynecological cancers can reduce variability among different observers when defining treatment targets, leading to more accurate treatment plans.

This imaging technique provides important functional information about tumors, which can help in developing advanced treatment strategies like dose escalation and 'dose painting', particularly beneficial for patients with locally advanced cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Use of 18F-FDG PET CT for External Beam Radiotherapy Planning in Gynaecological Malignancies. Kerr, A., Reed, N., Harrand, R., et al.[2019]

Positron emission tomography (PET) using (18)F-fluoro-2-deoxyglucose (FDG) is becoming more valuable for assessing gastrointestinal cancers.

This imaging technology helps in the evaluation of malignancies, potentially improving diagnosis and treatment planning for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluoro-2-deoxyglucose positron emission tomography in the evaluation of gastrointestinal malignancies. Chin, BB., Wahl, RL.[2019]

This study highlights the first reported case of an allergic reaction to fluorodeoxyglucose, a radiopharmaceutical used in PET/CT scans, in a patient undergoing repeated scans for pyriform sinus cancer.

As the use of PET/CT procedures increases, it is crucial to understand and manage potential adverse effects, such as allergic reactions, to ensure patient safety during these diagnostic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorodeoxyglucose-induced allergic reaction: a case report. Codreanu, I., Dasanu, CA., Weinstein, GS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3101722/

18F-FDG PET/CT Imaging In Oncology - PMC - PubMed Central The 2-year progression-free survival rate is 86% for patients with a negative post-treatment scan in comparison to 40% for those with persistent abnormal 18F- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3335332/

The role of FDG-PET/CT in gynaecological cancers - PMC An increase in sensitivity (from 37.6% to 69.4%) and accuracy (from 89.7% to 94.0%) and stable specificity (from 97.1% to 97.5%) was found with FDG-PET/CT ...

3. e-jyms.org e-jyms.org/journal/view.php?number=2802

Diagnostic performance of F-18 FDG PET or PET/CT for ... This meta-analysis of the data from 17 studies assessed the diagnostic performance of F-18 FDG PET and PET/CT in detecting disease recurrence

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24011472

Utility of 18F-FDG-PET/CT imaging in patients with ... Our study examined whether the results of a PET/CT scan changed the management plan as compared with conventional imaging. METHODS. Patients with gynecological ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/50/1/88

18F-FDG PET and PET/CT in the Evaluation of Cancer ... When using a cutoff value of 60% of baseline SUV, 18F-FDG PET/CT after 2 courses of chemotherapy had the best performance, with an accuracy of 87% for ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK580532/

Nuclear Medicine PET/CT Gastrointestinal Assessment ... - NCBI PET/CT is indicated for staging, restaging, and treatment response evaluation in gastrointestinal malignancies.

7. withpower.com withpower.com/trial/phase-3-vulvar-neoplasms-2-2018-3cc52

FDG-PET Guided Radiation for Gastrointestinal and ... The safety data for FDG-PET guided radiation treatment includes the ... outcomes for patients with specific gastrointestinal and gynecologic cancers.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1590865815002145

Role of fluorine 18 fluorodeoxyglucose positron emission ... FDG-PET has demonstrated good performances for the detection of gastric cancer recurrence, but not superior to those of CT scan [59]. The use of FDG-PET does ...