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FDG PET/CT Timing for Head and Neck Cancer with Metastasis

N/A

Recruiting

Led By Jason M Johnson

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

Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is testing how well PET/CT works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body.

Who is the study for?

This trial is for adults with head and neck squamous cell cancer that has spread, who have had chemoradiation. They must show signs of metastasis in the neck on CT or PET scans using fludeoxyglucose F-18.Check my eligibility

What is being tested?

The study is testing how well two timing approaches of FDG-PET/CT scans work in evaluating patients after they've received standard radiation and chemotherapy for their cancer.See study design

What are the potential side effects?

Potential side effects from the radioactive material used in PET/CT scans may include a slight risk of radiation exposure, which can lead to future cancers, and allergic reactions to the tracer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differences in L/B ratio

Optimal imaging time

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

Insomnia

Esophageal pain

Esophagitis

Chills

Weight loss

Hyperglycemia

Hypocalcemia

Arthralgia

Hypotension

Hypoalbuminemia

Sinus tachycardia

Pain

Bloating

Constipation

Hypokalemia

Peripheral sensory neuropathy

Aspiration

Alopecia

Skin and subcut tissue disord - Oth spec

Febrile neutropenia

Hypoxia

Soft tissue infection

Hypophosphatemia

Depression

Pharyngolaryngeal pain

Dysgeusia

Gastroparesis

Pain in extremity

Edema limbs

Stomach pain

Cardiac arrest

Thrombotic thrombocytopenic purpura

Esophageal hemorrhage

Esophageal obstruction

Lung infection

Sepsis

Tooth infection

Alkaline phosphatase increased

Back pain

Atelectasis

Cough

Epistaxis

Hiccups

Hoarseness

Pleural effusion

Pleuritic pain

Rash maculo-papular

Hypertension

Phlebitis

Superficial thrombophlebitis

Vascular disorders - Other, specify

Thromboembolic event

Blood and lymph sys disorders - Oth Spec

Palpitations

Sinus bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

FOLFOX Non-Responder

CP Responder

FOLFOX Responder

CP Non-Responder

CP No Cross-over

FOLFOX No Cross-over

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FDG PET/CT)Experimental Treatment3 Interventions

Patients receive fludeoxyglucose F-18 IV over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard CRT completion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,752 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,617 Total Patients Enrolled

1 Trials studying Metastasis

2 Patients Enrolled for Metastasis

Jason M JohnsonPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

123 Total Patients Enrolled

Media Library

Positron Emission Tomography Clinical Trial Eligibility Overview. Trial Name: NCT03575949 — N/A

Metastasis Research Study Groups: Diagnostic (FDG PET/CT)

Metastasis Clinical Trial 2023: Positron Emission Tomography Highlights & Side Effects. Trial Name: NCT03575949 — N/A

Positron Emission Tomography 2023 Treatment Timeline for Medical Study. Trial Name: NCT03575949 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are individuals being recruited for this trial?

"Affirmative. Clinicaltrials.gov has documented that this clinical trial is accepting participants, with the initial posting date having been June 15th 2018 and a recent update to October 13th 2022 occurring recently. The initiative seeks 50 patients at one site."

Answered by AI

Are there any available slots in this scientific research project?

"Present data on clinicaltrials.gov suggests that this trial is recruiting participants, having been posted to the site in mid-June 2018 and last updated in late October 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

2018. "Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03575949.