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Positron Emission Tomography for Meningioma

Phase 1
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial uses Gallium Ga 68-DOTATATE to see if it can help predict tumor growth in patients with meningiomas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Imaging with Gallium Ga 68-DOTATATE
Metabolic response to radiation therapy

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%
Insomnia
8%
Esophageal pain
8%
Esophagitis
8%
Chills
8%
Weight loss
8%
Hyperglycemia
8%
Hypocalcemia
8%
Arthralgia
8%
Hypotension
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%
Hypoxia
3%
Soft tissue infection
3%
Hypophosphatemia
3%
Depression
3%
Pharyngolaryngeal pain
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (gallium Ga 68-DOTATATE PET/CT)Experimental Treatment3 Interventions
Patients receive gallium Ga 68-DOTATATE IV over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Gallium Ga 68-DOTATATE
2018
Completed Phase 2
~30
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,629 Total Patients Enrolled
45 Trials studying Meningioma
4,224 Patients Enrolled for Meningioma
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,789 Total Patients Enrolled
2 Trials studying Meningioma
20 Patients Enrolled for Meningioma
Jason M JohnsonPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
160 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being admitted to this clinical investigation?

"Affirmative. Clinicaltrials.gov has verified that this research study is searching for participants, which was first posted on October 1st 2019 and last modified on September 28th 2022. A total of 12 volunteers are needed at a singular medical facility."

Answered by AI

Is there still room to enroll participants in this research project?

"According to clinicaltrials.gov, this research trial is still recruiting patients, having been initially published on October 1st 2019 and recently updated on September 28th 2022."

Answered by AI

To what extent can Positron Emission Tomography be detrimental to an individual's health?

"There is limited evidence available to assess the safety of positron emission tomography, thus it has been assigned a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
2019. "Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03953131.
~2 spots leftby Apr 2025
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