FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Duke University
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment.
Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.
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.
What data supports the idea that FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers is an effective treatment?
The available research shows that FDG-PET Guided Radiation is effective for gastrointestinal and gynecologic cancers. For gastrointestinal cancers, FDG-PET is particularly good at detecting and staging recurrent colorectal cancer, with a high accuracy rate. It is also effective in diagnosing pancreatic cancer when a suspicious mass is seen on a CT scan. For gynecologic cancers, FDG-PET is used in planning radiation treatment for cervical, vulvar, and vaginal cancers, and it helps in evaluating the treatment's success. Compared to other methods, FDG-PET is more accurate in detecting certain types of cancer spread, which can lead to better treatment planning and outcomes.
12345What safety data exists for FDG-PET guided radiation treatment?
The safety data for FDG-PET guided radiation treatment includes the potential for immune-related adverse events (irAEs) that can be detected on 18F-FDG PET/CT imaging, particularly affecting the endocrine, cutaneous, and gastrointestinal systems. Additionally, there is a reported case of an allergic reaction to fluorodeoxyglucose used in PET/CT scans. It is important to differentiate between treatment-related effects and disease to manage these adverse events effectively.
678910Is FDG-PET Guided Radiation a promising treatment for gastrointestinal and gynecologic cancers?
Yes, FDG-PET Guided Radiation is promising because it helps doctors see cancer more clearly, which can improve treatment planning and monitoring. It is especially useful for detecting cancer spread and checking how well treatment is working, making it a valuable tool in treating gastrointestinal and gynecologic cancers.
2341112Eligibility Criteria
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.
+3 more
Exclusion Criteria
Breastfeeding
Positive serum pregnancy test
No gross disease visible on imaging at the start of radiotherapy
+2 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single arm interventional studyExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Positron emission tomography for the diagnosis and management of patients with gastrointestinal malignancies. [2016]F-18 fluorodeoxyglucose positron emission tomography (FDG-PET) can play an important role in evaluating patients who have locally advanced diseases and in recurrence detection and restaging in patients who have gastrointestinal tract malignancies. Introduction of an integrated PET/CT system enabled the precise co-evaluation of function and morphology and improved the diagnostic ability of FDG-PET. Application of FDG-PET for treatment response evaluation and prognosis prediction is becoming important. Development of novel PET probes is expected to improve the characterization of individual cancer and to contribute to individualized patient management.
The Role of PET Imaging in Gynecologic Radiation Oncology. [2018]The goal of this review is to discuss the current utility of fluorine-18-fluorodeoxyglucose (FDG)-PET for radiation oncologists who treat gynecologic malignancies. FDG-PET/computed tomography (CT) is recommended for baseline assessment in cervical cancer and for staging in vulvar and vaginal cancer. The authors use FDG-PET/CT in definitive radiation treatment planning for cervical, vulvar, and vaginal cancer. PET may be helpful for salvage radiation treatment planning for any recurrent gynecologic malignancy. There are published data to support the use of PET in posttreatment evaluation of cervical and vulvar cancer.
Evaluating the Use of 18F-FDG PET CT for External Beam Radiotherapy Planning in Gynaecological Malignancies. [2019]To evaluate the evidence for the use of fluorine-18-fluorodeoyglucose (18F-FDG) PET CT in external beam radiotherapy planning for treatment of gynaecological malignancies.
FDG-PET scanning in the diagnosis of gastrointestinal cancers. [2019]This review deals with the current, well-established indications for two-(18F)-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) scanning in patients with gastrointestinal cancers. FDG-PET is a non-invasive, functional imaging technique. FDG exploits the native glucose transporter to enter the cell. Since many tumours have enhanced glucose uptake, FDG is readily accumulated in malignant cells and can be detected by a PET camera. FDG-PET has been established as an important diagnostic tool in clinical oncology. This review deals with the current, well-established indications for FDG-PET scanning in patients with gastrointestinal cancers. In the current practice, FDG-PET is most commonly used to stage oesophageal carcinoma, to detect and stage recurrence of colorectal carcinoma and to differentiate between benign and malignant pancreatic lesions. The benefit of FDG-PET scanning in patients with oesophagus carcinoma is best established in stage IV disease, as the diagnostic accuracy to detect metastatic disease is higher compared to the combination of computed tomography (CT) and endoscopic ultrasound (EUS). In patients with a history of colorectal carcinoma, FDG-PET scanning is particularly effective in diagnosing recurrent disease, especially in those with a rising carcinoembryonic antigen without a suspect lesion on conventional imaging. Large series have indicated that the sensitivity and specificity for detecting recurrent colorectal carcinoma are in the range of 87%-100% and 66%-100%, respectively. Equally, FDG-PET has a high sensitivity (68%-96%) and specificity (78%-100%) in detecting pancreatic carcinoma in patients with a suspicious-looking pancreatic mass on CT scan. Lastly, we focus on the use of FDG-PET as a modality for early monitoring of treatment response in patients with gastrointestinal stromal cell tumours. Without doubt, future developments will further establish the diagnostic role of the FDG-PET scan in the care of patients with gastrointestinal cancers.
Therapy Monitoring with Fluorine-18 FDG-PET and Fluorine-18 FDG-PET/CT. [2016]PET with the glucose analog [18F]-FDG is increasingly used to monitor tumor response in patients undergoing chemotherapy and chemoradiotherapy. The clinical value of FDG PET for differentiation of residual tumor and therapy-induced fibrosis has been documented for gastrointestinal cancer. Furthermore, quantitative assessment of therapy-induced changes in tumor [18F]-FDG uptake may allow the prediction of tumor response and patient outcome very early in the course of therapy. This suggests that FDG PET may be used to identify nonresponders early during neoadjuvant chemoradiotherapy, allowing for early modifications of the treatment protocol.
Immunotherapy-related adverse effects on 18F-FDG PET/CT imaging. [2021]18F-Fluorodeoxyglucose positron emission tomography/CT imaging plays a key role in oncological imaging including in staging, radiotherapy planning, treatment response and recurrence assessment. Immunotherapies represent a major advance in cancer therapy for a number of tumours with resulting survival benefit. However, a wide range of immune related adverse events (irAEs), some of which can be apparent on imaging, have been reported. These involve many organ systems but particularly endocrine, cutaneous and gastrointestinal systems. Early detection of irAEs is essential to aid diagnosis and management of patients and to reduce associated morbidity. In addition, it is important to not mistake treatment related effects for disease.This pictorial review aims to identify common irAEs and changes seen on 18F-fluorodeoxyglucose positron emission tomography/CT.
18F-Fluoro-2-deoxyglucose positron emission tomography in the evaluation of gastrointestinal malignancies. [2019]Positron emission tomography with (18)F-fluoro-2-deoxyglucose is an imaging technology that is demonstrating increasing utility in the evaluation of gastrointestinal malignancies.
Variants and Pitfalls in PET/CT Imaging of Gastrointestinal Cancers. [2023]In the past two decades, PET/CT has become an essential modality in oncology increasingly used in the management of gastrointestinal (GI) cancers. Most PET/CT tracers used in clinical practice show some degree of GI uptake. This uptake is quite variable and knowledge of common patterns of biodistribution of various radiotracers is helpful in clinical practice. 18F-Fluoro-Deoxy-Glucose (FDG) is the most commonly used radiotracer and has quite a variable uptake within the bowel. 68Ga-Prostate specific membrane antigen (PSMA) shows intense uptake within the proximal small bowel loops. 11C-methyl-L-methionine (MET) shows high accumulation within the bowels, which makes it difficult to assess bowel or pelvic diseases. One must also be aware of technical artifacts causing difficulties in interpretations, such as high attenuation oral contrast material within the bowel lumen or misregistration artifact due to patient movements. It is imperative to know the common variants and benign diseases that can mimic malignant pathologies. Intense FDG uptake within the esophagus and stomach may be a normal variant or may be associated with benign conditions such as esophagitis, reflux disease, or gastritis. Metformin can cause diffuse intense uptake throughout the bowel loops. Intense physiologic uptake can also be seen within the anal canal. Segmental bowel uptake can be seen in inflammatory bowel disease, radiation, or medication induced enteritis/colitis or infection. Diagnosis of appendicitis or diverticular disease requires CT correlation, as normal appendix or diverticulum can show intense uptake. Certain malignant pathologies are known to have only low FDG uptake, such as early-stage esophageal adenocarcinoma, mucinous tumors, indolent lymphomas, and multicystic mesotheliomas. Response assessment, particularly in the neoadjuvant setting, can be limited by post-treatment inflammatory changes. Post-operative complications such as abscess or fistula formation can also show intense uptake and may obscure underlying malignant pathology. In the absence of clinical suspicion or rising tumor marker, the role of FDG PET/CT in routine surveillance of patients with GI malignancy is not clear.
Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">Immunotherapy is an effective treatment method for cancer cells with humoral and cellular immune mechanisms of action but triggers an inflammatory response and disrupts standard protective immune tolerance. Early detection of immune-related adverse events (irAEs) on PET/CT is crucial for patient management and subsequent therapy decisions. In this study, we aimed to evaluate the impact of 18F-FDG PET/CT on detecting of irAEs in patients receiving immunotherapy.
Fluorodeoxyglucose-induced allergic reaction: a case report. [2019]The number of diagnostic positron emission tomography/computed tomography (PET/CT) procedures performed in the USA and worldwide is rapidly increasing. Although the benefits of these procedures are obvious, the increasing use of radiopharmaceuticals requires a better understanding of potential adverse affects and their proper management. We present herein the first report of an allergic reaction to fluorodeoxyglucose in the setting of repeated PET/CT scans for restaging purposes in a patient with pyriform sinus cancer.
[[18F]-FDG-PET in the diagnostics of gastrointestinal tumors]. [2016]Positron emission Tomography (PET) with 2-[(18)F]-fluoro-2-deoxy-d-glucose (FDG) is a functional imaging technique with increasing value in special diagnostic fields of gastrointestinal tumours. In the initial staging of esophageal and gastric cancer, FDG-PET is useful in the staging of patients with advanced but local resectable disease. The detection of distant metastases results in an up-staging, and these patients should not be treated by surgery. Furthermore, FDG-PET is sufficient for monitoring early therapy responses after neoadjuvant treatment and enables one to select non-responders who may benefit from therapy alterations. Major indications for FDG-PET in patients with rectal carcinoma are therapy monitoring and diagnosis of relapses, especially the differentiation between tumour and scar and also the localisation of tumour manifestations in cases with increasing tumour markers. FDG-PET is very efficient in the imaging of pulmonal and hepatic metastases of colorectal cancer but not in lymph node staging. In diagnostic procedures for pancreatic carcinoma, FDG-PET can be recommended to explore the dignity of pancreatic lesions and in the imaging of tumour relapses. For gastrointestinal stroma tumours, FDG-PET is useful for the monitoring of therapy and the initial staging. For imaging of hepatocellular carcinoma and carcinoma of the gall bladder, FDG-PET is not sufficient.
PET/CT Imaging in Gynecologic Malignancies Other than Ovarian and Cervical Cancer. [2016]Fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) is an imaging modality used for staging, assessing response to therapy, and diagnosis of recurrent cervical and ovarian cancer. The potential role of FDG-PET/CT in other gynecologic malignancies such as endometrial cancer, uterine sarcomas, vaginal, and vulvar cancer has not been fully explored.