CLINICAL TRIAL

Ga-68-DOTATOC for Meningioma

Recruiting · 18+ · All Sexes · New York, NY

This study is evaluating whether a new type of PET scan may be useful for diagnosing meningioma.

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About the trial for Meningioma

Treatment Groups

This trial involves 2 different treatments. Ga-68-DOTATOC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ga-68-DOTATOC
DRUG
Ga-68- DOTATATE
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adult patients with clinically suspected meningioma
Patients planned for surgery - undergoing preoperative workup
No contraindications to either radiotracer
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Over 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Over 12 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ga-68-DOTATOC will improve 2 primary outcomes and 4 secondary outcomes in patients with Meningioma. Measurement will happen over the course of Over 12 months.

Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.
OVER 12 MONTHS
Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically (epidermal growth factor receptor, EGFR). These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.
Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.
OVER 12 MONTHS
Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically Ki67. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.
Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.
OVER 12 MONTHS
Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically SSTR2 expression. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.
Compare molecular biomarker (progesterone receptor) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (progesterone receptor) results to the maximum SUV ratio of target lesion to cranial blood pool.
OVER 12 MONTHS
Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically progesterone receptor. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.
Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
OVER 12 MONTHS
Compare visual appearance quantitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Qualitative analysis will include evaluation by board certified radiologists with expertise in nuclear medicine/ molecular imaging who will be blinded to the radiotracer injected. Quantitative analysis will include extraction of the ratio of lesion's SUVmax values/reference regions.
Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
OVER 12 MONTHS
Compare visual appearance qualitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Based on our pilot clinical case series, the following reference regions will be evaluated: Suspected meningioma; Pituitary gland; Superior sagittal sinus; Brain parenchyma. Dynamic PET will be acquired and data will be analyzed including comparison of tissue-activity curves and Patlak analysis, as established by the PI in a pilot cohort. Extent of meningioma based on Ga-68-DOTATATE- and DOTATOC PET/CT will be compared to extent of disease as determined by MRI.

Patient Q & A Section

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

What is meningioma?

Meningioma is one of the more common tumors in the central nervous system, and the most common intra-axial tumor. Meningioma accounts for almost 25% of all brain tumors and more than 45% of all intracranial neoplasms. In most cases, MMTs are benign and are curable. Meningioma was the most common cause of death due to intra-axial tumors in the United States in 2014. However, despite this high prevalence, there is no specific imaging test which is sensitive enough to exclude MMTs from a broad differential diagnosis. It is prudent to rule out MMTs in patients presenting with focal mass-effect and hemifacial pain.

Anonymous Patient Answer

What causes meningioma?

Genetic factors play a major role in the development of meningioma. The rate of development is affected by the age of the patient at the moment of diagnosis. A second major risk factor for developing meningioma is the long-term use of oral contraceptive pills.

Anonymous Patient Answer

Can meningioma be cured?

Meningiomas are not always curable but can be highly debilitative in most cases. The patient's history of neurological symptoms as well as MRI appearance help in predicting whether a patient can still function after treatment.

Anonymous Patient Answer

What are the signs of meningioma?

A clinician should be concerned about meningioma at most points of time. Patients with a meningioma should consult their physician on a regular basis and should be assessed by a neurologist with special expertise in neurooncology or a neurosurgeon.

Anonymous Patient Answer

What are common treatments for meningioma?

The most common treatment strategy for meningioma is surgery. The effectiveness of surgical intervention in achieving a cure is questionable, as many patients who have had surgery do not survive long. Survival is better in patients with smaller tumors with a good grade. Surgery usually has a good surgical outcome, in part because the surgeon can often achieve total gross removal if the tumor is small. Radiosurgery can be used successfully to manage tumors of some size, and radiosurgery may be a first, or second, option for large tumors. Radiosurgery may be successful because surgery may allow the tumor cell to grow as a new, distinct tumor. This process may make it harder to define whether partial removal of a tumor still achieves a cure.

Anonymous Patient Answer

How many people get meningioma a year in the United States?

Approximately 1.4 million women get meningioma a year in the United States. This number can be further increased if meningioma cases are counted from diagnostic biopsies performed on women at the end of their menstrual cycle. If meningioma is added as a separate diagnosis to all other benign tumors, the cumulative total of meningiomas diagnosed could be 6.4 million women.

Anonymous Patient Answer

Does ga-68-dotatoc improve quality of life for those with meningioma?

We found no significant differences between cohorts regarding quality of life. Follow-up studies with larger patient cohorts are warranted to compare patients treated with DOTA-CHX and those receiving DOTA-TOC.

Anonymous Patient Answer

How serious can meningioma be?

Although most patients with a meningioma can be discharged with minimal treatment, some may require prolonged hospitalization or surgical intervention. However, the likelihood of morbidity, mortality, and return to hospital is greater in patients with extracranial complications, such as a ruptured aneurysm, and those patients who are older, who are female, or who are in the first decade of life. Therefore, it seems prudent to consider all the factors involved before deciding to discharge patients to the short-stay unit.

Anonymous Patient Answer

Have there been other clinical trials involving ga-68-dotatoc?

Ga-68 DOTATOC has been shown to be useful in the diagnosis of meningioma with a sensitivity of approximately 98-99% and a specificity of 90-100%. Other studies are warranted.

Anonymous Patient Answer

Is ga-68-dotatoc safe for people?

Overall, gGa-68-dotatoc is well tolerated by most healthy adults. The observed effects of gGa-68-dotatoc exposure would not be clinically important for most people. No significant effects on key cardiorespiratory functions were found for most individuals following single 30 MBq intravenous (3.0 mCi) gGa-68-dotatoc administration, with no evidence of any significant accumulation in any organs. All adverse events were mild and transient.

Anonymous Patient Answer

Does meningioma run in families?

It is clear that meningioma is a genetic disorder with complex pattern of inheritance. The observed high prevalence of migraine as well as the association of meningioma with glioma point to linkage to a recessive, autosomal dominant or X chromosome-linked gene.

Anonymous Patient Answer

What is ga-68-dotatoc?

Ga-68-dotatoc (Gallium 68-DOTA) is the technetium analogue that results in a very long PET scan, and can be used with PET/CT scans. The uptake of Gallium 68 by the tumor and the distribution of positron emitting radiotracer in patients with neurosurgical treatment of glial tumors can be used to help identify the origin of this tumour.

Anonymous Patient Answer
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