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PET/MRI Scan for Cervical Cancer

Phase < 1
Waitlist Available
Led By Sanaz Javadi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors > 4 cm
Suspected cervical cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial uses PET/MRI scans to check for the spread of cervical cancer in patients who are eligible for surgery.

Who is the study for?
This trial is for individuals with suspected early-stage cervical cancer (IA1-IB3) that can potentially be removed by surgery. Participants must not have tumors larger than 4 cm, should have no issues with undergoing MRI scans, and will be having their surgical procedure at MD Anderson.
What is being tested?
The study is evaluating the effectiveness of PET/MRI scans using Gadobutrol and Fludeoxyglucose F-18 in assessing the spread of early-stage cervical cancer before surgery.
What are the potential side effects?
Potential side effects may include reactions to contrast agents like Gadobutrol such as headache, nausea, or allergic reactions; and discomfort during the PET/MRI scan process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cervical cancer is in the early stages and my tumor is not larger than 4 cm.
Select...
I am suspected to have cervical cancer.
Select...
I am scheduled for surgery at MD Anderson.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
Secondary study objectives
Assessing the Lymph node involvement by PET/MRI
Inter-observer variability of PET/MR
Quantitative imaging parameters of the tumor

Side effects data

From 2023 Phase 2 trial • 257 Patients • NCT01333033
79%
Nausea
64%
Platelet count decreased
46%
Vomiting
46%
Neutrophil count decreased
41%
Paresthesia
41%
Diarrhea
38%
Lymphocyte count decreased
28%
Dysphagia
26%
Dyspnea
23%
Fatigue
21%
White blood cell decreased
18%
Anemia
15%
Anorexia
15%
Headache
13%
Peripheral motor neuropathy
13%
Dehydration
10%
Laryngopharyngeal dysesthesia
10%
Flu like symptoms
10%
Fever
10%
Hyponatremia
10%
Myalgia
8%
Hypotension
8%
Insomnia
8%
Esophageal pain
8%
Esophagitis
8%
Chills
8%
Weight loss
8%
Hyperglycemia
8%
Hypocalcemia
8%
Arthralgia
5%
Hypoalbuminemia
5%
Sinus tachycardia
5%
Pain
5%
Bloating
5%
Constipation
5%
Hypokalemia
5%
Peripheral sensory neuropathy
5%
Aspiration
5%
Alopecia
5%
Skin and subcut tissue disord - Oth spec
5%
Febrile neutropenia
3%
Depression
3%
Soft tissue infection
3%
Hypoxia
3%
Pharyngolaryngeal pain
3%
Hypophosphatemia
3%
Dysgeusia
3%
Gastroparesis
3%
Pain in extremity
3%
Edema limbs
3%
Stomach pain
3%
Cardiac arrest
3%
Thrombotic thrombocytopenic purpura
3%
Esophageal hemorrhage
3%
Esophageal obstruction
3%
Lung infection
3%
Sepsis
3%
Tooth infection
3%
Alkaline phosphatase increased
3%
Back pain
3%
Atelectasis
3%
Cough
3%
Epistaxis
3%
Hiccups
3%
Hoarseness
3%
Pleural effusion
3%
Pleuritic pain
3%
Rash maculo-papular
3%
Hypertension
3%
Phlebitis
3%
Superficial thrombophlebitis
3%
Vascular disorders - Other, specify
3%
Thromboembolic event
3%
Blood and lymph sys disorders - Oth Spec
3%
Palpitations
3%
Sinus bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFOX Non-Responder
CP Responder
FOLFOX Responder
CP Non-Responder
CP No Cross-over
FOLFOX No Cross-over

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (PET/MRI)Experimental Treatment4 Interventions
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Gadobutrol
FDA approved
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,555 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,566 Total Patients Enrolled
Sanaz JavadiPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Positron Emission Tomography Clinical Trial Eligibility Overview. Trial Name: NCT04219904 — Phase < 1
Cervical Cancer Research Study Groups: Diagnostic (PET/MRI)
Cervical Cancer Clinical Trial 2023: Positron Emission Tomography Highlights & Side Effects. Trial Name: NCT04219904 — Phase < 1
Positron Emission Tomography 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219904 — Phase < 1
~3 spots leftby Sep 2025
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