Nutritional and Metabolic Diseases

All Conditions

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Hypoglycemia

Hyperinsulinism

Congenital Hyperinsulinism

Nesidioblastosis

Insulinoma

Metabolic Diseases

Glucose Metabolism Disorders

Adenoma

Adenoma, Islet Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Infant, Newborn, Diseases

Pancreatic Cancer

All Drugs and Chemicals

Cardiotonic Agents

Dihydroxyphenylalanine

Dopamine

Dopamine Agents

Neurotransmitter Agents

A dose of Fluorodopa F 18, 3-6 MBq/Kg (0.08-0.16 mCi/kg), will be injected intravenously into the subject under the direct supervision of the radiology sub-investigator. Then, the PET imaging procedure will begin and proceed for up to 70 minutes after injection. An abdominal CT image will be made using intravenous contrast. Both images, PET and CT, will be co-localized by the radiologist for interpretation.

Fluorodopa F 18

Deborah Rafferty, PhD

Paul Thornton, MD

Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient.

The purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.

Congenital Hyperinsulinism (HI) is a disorder of insulin secretion that causes profound hypoglycemia leading to significant morbidity. It is the most common form of persistent neonatal hypoglycemia, and the most dangerous. Inappropriate insulin secretion causes not only hypoglycemia but also inability to release free fatty acids from adipose tissue and inability to release glycogen from the liver. Hence the brain is deprived of all the major fuel sources (glucose, beta-hydroxybutyrate and lactate) for energy thus leading to the high incidence of brain damage. In up to 50% of cases of congenital hyperinsulinism, medical therapy fails and surgical resection of the pancreas is necessary. Previous techniques developed to differentiate those patients with focal HI in whom surgery could result in a cure are very invasive and put the infants at risk for hypoglycemic brain damage or arterial thrombosis.

It is known that the beta cells in the pancreatic islets, similar to other neuroendocrine tissues, contain amino acid decarboxylase (AADC). Beta cells take up L-Dopa and convert it into dopamine by AADC. It was proposed that as other neuroendocrine tumors such as phaeochromocytoma and carcinoid tumors express AADC and can be very easily visualized using Fluorodopa F 18 PET then so also would the pancreas be easily and accurately visualized. After initial reports demonstrated the effectiveness, safety and accuracy, there have been now over 200 patients with HI reported in the literature who have had Fluorodopa F 18 PET scans with suggestions that referral to major HI centers for Fluorodopa F 18 PET CT is now an integral part of standard of care management of patients with HI that require surgery. Fluorodopa F 18 PET scanning for patients with Hyperinsulinism is now established in Europe and Australia, and has close to 95% sensitivity. When linked to Computed Tomography (CT) image of the pancreas, Fluorodopa F 18 PET allows the surgeon to image the pancreas in three dimensions, to even more accurately identify the site of the focal lesion, increasing the chance of a sufficient partial pancreatectomy to cure the patient.

Similarly, insulinomas are neuroendocrine cell tumors that are typically benign (90%) and very rare occurring in 1-4 per million of the population with \> 50% occurring in adults \>age 25 years. Biochemical differentiation of insulinomas from congenital hyperinsulinism may be aided by the use of the pro-insulin:insulin ratio, by the age of presentation and by the history. The standard of care for insulinoma is to remove them once identified, rather than long term medical treatment. Current imaging techniques include CT scan pancreas, endoscopic ultrasound of the pancreas and MRI pancreas however despite using these modalities in some patients the insulinoma may not be found. 18F-DOPA has been shown to be superior than MIBG scanning for neuroendocrine tumors such as phaeochromocytoma, but there is very little data in patients with insulinoma. Moreover, patients with MEN 1 and insulinoma may have more than one tumor, which if missed with conventional imaging could result in failure to cure with surgery.

The objectives of this study are:

1. To determine, using Positron Emission Tomography, whether or not the uptake of a radiopharmaceutical agent, Fluorodopa 18F (18F-DOPA) produced in a cyclotron located at a distance far from the imaging center will produce qualitatively adequate pancreatic images in patients with congenital hyperinsulinism
2. To determine, using direct comparisons, whether or not Fluorodopa 18F Positron Emission Tomography (18F-DOPA PET) combined with Computed Tomography (CT) will produce pancreatic images matching the gold-standard of histopathological findings at surgery for partial or complete pancreatectomy in the treatment of patients with congenital hyperinsulinism
3. To determine, using direct comparisons, whether or not Fluorodopa 18F Positron Emission Tomography (18F-DOPA PET) combined with Computed Tomography (CT) will produce pancreatic images matching the gold-standard of histopathological findings at surgery for insulinomas
4. To determine the best way to interpret the 18F-DOPA PET scans comparing SUV max:SUV sub max at a ratio of the current 1.5, a suggested 1.3 and by using visual inspection of the images.

Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

The Use of Fluorodopa F 18 Positron Emission Tomography Combined With Computed Tomography in Congenital Hyperinsulinism and Insulinoma

Positron Emission Tomography will be used to determine whether or not the uptake of a radiopharmaceutical agent, Fluorodopa F 18, produced in a cyclotron located at a distance far from the imaging center will produce qualitatively adequate pancreatic images in patients with congenital hyperinsulinism

Investigators will directly compare pancreatic images from Fluorodopa F 18 PET combined with Computed Tomography versus the gold-standard of histopathological findings at surgery in subjects who received a partial or complete pancreatectomy

Investigators will compare SUV max to SUV sub max at a ratio of the current 1.5, a suggested 1.3 and by using visual inspection of the images.

Cook Children's Health Care System

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Anti-Dyskinesia Agents

Antineoplastic Agents

Amino Acids

Levodopa

Fluorides

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Protective Agents

Antiparkinson Agents

Alanine

Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide PO on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.

Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO QD concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.

Accelerated Hypofractionated Radiation Therapy

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Quality-of-Life Assessment

Questionnaire Administration

Radiation Therapy

Biospecimen Collection

Clinical Trials Referral Office

Sujay A. Vora, M.D.

Daniel M. Trifiletti, M.D.

William G. Breen, M.D.

This phase II trial compares the effect of short course radiotherapy (RT) to standard course RT for the treatment of patients diagnosed with glioblastoma (GBM). The researchers want to learn whether the shorter course treatment is non-inferior (not worse than the standard of care), for patients with GBM. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Short course radiotherapy delivers higher doses of radiation over a shorter period of time and may kill more tumor cells and have fewer side effects.

PRIMARY OBJECTIVE:

I. To demonstrate non-inferior 12-month overall survival (OS) of patients with GBM treated with dose escalated hypofractionated radiotherapy compared to standard of care.

SECONDARY OBJECTIVES:

I. To demonstrate the safety of short-course radiotherapy via physician-reported grade (G) 3+ toxicity.

II. To explore patient-reported outcomes to demonstrate favorable quality of life with short-course radiotherapy for GBM.

III. To analyze the impact of shortening the treatment duration on treatment related lymphopenia and absolutely lymphocyte counts.

EXPLORATORY OBJECTIVES:

I. To determine the cost-effectiveness of the 5-fraction treatment regimen compared to standard of care.

II. To explore the impact on the immune system with the 5-fraction treatment regimen. Immune phenotyping will be assessed by Flow Cytometry and cytometry by flight (CyTOF).

III. To analyze series of cytokine levels over time. IV. To assess patterns of failure, specifically focusing on differences in volume delineation via Fluorodopa F 18 (FDOPA) and magnetic resonance imaging (MRI) and recurrences in-field versus (vs.) out of field.

V. To conduct a subgroup analysis for just patients =\< 65 cc. VI. To conduct a subgroup analysis for just patients with and without tumor treating fields.

VII. To analyze patient demographic data compared to historical controls to determine whether the short-course treatment regimen improves access to underserved populations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide orally (PO) on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO daily (QD) concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity.

All patients undergo positron emission tomography/computed tomography (PET/CT) with 18-F-DOPA administered intravenously (IV) prior to RT on study, and undergo MRI throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.

After completion of study treatment, patients are followed up every 2 months for the first year, every 3 months for the second year, and every 4 months for the third year. After 3 years, clinical outcomes are monitored at least once a year until 5 years after treatment.

The MRI scan indicating progressive disease will be fused with our treatment planning scan and the region of progression will be contoured by an investigator blinded to the GTV_MRI, T2_FLAIR_NCET, GTV_PET, PTV_high, and isodose lines.

Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

Comparisons between arms will be made by using a one-sided non-inferiority test of the difference in proportions with a non-inferiority limit of 10% and alpha level of .10. All patients meeting eligibility criteria who have signed a consent form, were randomized, and started treatment will be considered evaluable.

Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test for each time point. All patients meeting the eligibility criteria who signed a consent form and started treatment will be in the analysis.

Changes over time from baseline will be compared between arms using the 2-sample t-test (or Wilcoxon Rank-Sum test for non-normal data). All patients meeting the eligibility criteria who have signed a consent form, started treatment, and have non-missing data on these questionnaires will be evaluable for these analyses. Changes will be measured from baseline over time of study.

Changes over time from baseline will be compared between arms using the EORTC QLQ-C30 questionnaire. All patients meeting the eligibility criteria who have signed a consent form, started treatment, and have non-missing data on these questionnaires will be evaluable for these analyses. Score is caluclated from the mean of 13 of the 15 QLQ-C30 scales.

Changes over time from baseline will be compared between arms using the EORTC-BN20 questionnaire. All patients meeting the eligibility criteria who have signed a consent form, started treatment, and have non-missing data on these questionnaires will be evaluable for these analyses on a scale of 1-4, 1 being the lesser degree and 4 being the highest degree.

Lymphocyte count at nadir will be compared between arms using the 2-sample t-test (or Wilcoxon Rank-Sum test for non-normal data). Additionally, the absolute change in lymphocyte count from pretreatment to end of RT will be compared between arms using an analysis of covariance (ANCOVA).

Mayo Clinic

Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.

Proton Beam Radiation Therapy

Sujay A Vora

This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.

PRIMARY OBJECTIVE:

I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR) image (or PET/computed tomography \[CT\]) information with historical controls.

SECONDARY OBJECTIVES:

I. Compare progression free survival at 12 months after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional MR image information with historical controls.

II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy treatment including areas of high 18F-DOPA-PET uptake (T/N \> 2.0).

CORRELATIVE RESEARCH OBJECTIVES:

I. Compare radiotherapy (RT) treatment volumes defined by MR only with RT treatment volumes defined with both PET and MR information for grade IV glioma patients.

II. Compare differences in RT volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume (relCBV) from perfusion MRI (pMRI) as well as differences in RT volumes identified using biopsy-validated thresholds as tumor extent comparing 18F-DOPA uptake and diffusion maps from diffusion tensor imaging (DTI) will be evaluated.

III. Evaluate quality of life after radiotherapy using European Organization for Research and Treatment of Cancer (EORTC) questionnaires compared with historical controls from Keim-Guibert et al.

IV. Compare differences in proton radiation planning utilizing radiobiologic modeling/evaluation techniques performed at Mayo Clinic Rochester to linear energy transfer distribution evaluation at Mayo Clinic Arizona.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, and then periodically for up to 5 years.

18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy

Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma

Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance (MR) only and treatment volumes defined with both positron emission tomography (PET) and MR information.

QOL surveys will be compared to data from historical controls. Quality of life will be assessed at baseline and at each magnetic resonance imaging (MRI) evaluation (up to 6 evaluations). QOL will be measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30.

Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between proton plan metrics based off the two modeling/evaluation techniques.

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology.

The distribution of progression free survival times groups will be estimated using the method of Kaplan-Meier (1958).

The rate of acute and late treatment-related toxicities for newly diagnosed high-grade glioma patients treated with fluorodopa F 18-positron emission tomography (18F-DOPA PET) image-guided hypofractionated proton beam therapy will be determined, with acute radiotherapy (RT) toxicities graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Treatment (18F-DOPA, PET/MRI, PET/CT, Temozolomide)

Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.\> \> Computed Tomography: Undergo PET/CT\>

\> Fluorodopa F 18: Given IV\>

\> Magnetic Resonance Imaging: Undergo PET/MRI\>

\> Positron Emission Tomography: Undergo PET/CT or PET/MRI\>

\> Proton Beam Radiation Therapy: Receive proton beam RT\>

\> Quality-of-Life Assessment: Ancillary studies\>

\> Questionnaire Administration: Ancillary studies\>

\> Temozolomide: Drug

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Corticosteroid therapy at study entry?

IDH1 mutant

IDH1 Wildtype

Path result/Molecular factors

ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. \> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. \> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. \> ECOG = 0 is better. ECOG = 2 is worse.

ECOG Performance Status

Neurological Deficit

History of seizure

Gross total resection

Subtotal resection

Biopsy

Extent of surgery

Methylated

Unmethylated

Not available

MGMT

Family history of brain tumor

Use of alternating electrical therapy

Dr Sujay Vora

Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.

\>

\> Computed Tomography: Undergo PET/CT

\>

\> Fluorodopa F 18: Given IV

\>

\> Magnetic Resonance Imaging: Undergo PET/MRI

\>

\> Positron Emission Tomography: Undergo PET/CT or PET/MRI

\>

\> Proton Beam Radiation Therapy: Receive proton beam RT

\>

\> Quality-of-Life Assessment: Ancillary studies

\>

\> Questionnaire Administration: Ancillary studies

\>

\> Temozolomide: Drug

Overall Survival (OS)

Progression Free Survival

Incidence of Adverse Events (AEs)

Radiotherapy (RT) Treatment Volumes

Quality of Life (QOL)

Differences in Proton Radiation Planning

Overall Study

Symptoms and General Pathology

Recurrence

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Anti-Infective Agents

Metronidazole

Patients receive 18F-DOPA IV and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

Receive standard of care radiation therapy

Surgical Procedure

Clinical Trial Referral Office

Deanna H. Pafundi, Ph.D.

This study evaluates the use of a new imaging agent called fluorodopa F 18 (18F-DOPA) with positron emission tomography/magnetic resonance imaging (PET/MRI) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas that are new or that have come back (recurrent). Though there have been improvements in treatment options for soft tissue sarcomas, there is currently a need for a non-invasive way to determine a patient's potential benefit from receiving one of these treatments. 18F-DOPA with PET/MRI allows a patient's tumor to be visualized and their response to a given treatment assessed.

PRIMARY OBJECTIVE:

I. Determine the correlation between 18F-DOPA PET/MRI quantitative metrics after neoadjuvant treatment (pre-surgery) with percent tumor necrosis.

SECONDARY OBJECTIVE:

I. Compare the changes in 18F-DOPA PET/MRI quantitative metrics between baseline (before radiotherapy \[RT\]) and after RT, but before surgery with percent tumor necrosis.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI over 60 minutes before standard of care radiotherapy and/or before standard of care surgery.

An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas

Utility of 18F-DOPA PET/MRI Metrics as a Biomarker for Treatment Response Assessment in Sarcoma Patients: A Pilot Study

Pathologic evaluation of resected specimens by an expert pathologist will be the gold standard for tumor diagnosis and treatment response assessment in this study. Following definitive surgery, the tumor should be examined to determine pathologic response. Since the effect of the preoperative RT may not be uniform throughout the tumor, adequate sampling is required to grade the pathologic response accurately. Tumor's pathologic response will be performed utilizing the grading system below as a guideline: grade I is defined as the percentage of necrosis less than 50%, grade II is defined as the 50%-89% necrosis in the sample, grade III is defined as 90% - 99% necrosis and grade IV is defined as 100% necrosis. The pathological endpoint is defined as the indicator of whether the percentage of necrosis is \> 90%.

Imaging endpoints include SUV uptake value mean characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Imaging endpoints include SUV maximum characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Imaging endpoints include tumor to normal SUV characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Imaging endpoints include total metabolic tumor volume characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Imaging endpoints include total tumor glycolysis characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Imaging endpoints include tumor histogram characteristic. Five patients will be enrolled before RT for additional PET scan for comparison of pre-RT and post-RT SUV metrics, correlated with pathology after surgery, for evaluation of 18F-DOPA PET as a marker for response assessment.

Correlated with pathologic response. The correlation between imaging measures and pathologic response will be evaluated using a logistic regression model for each one of the four imaging modalities separately. For each subject, 12-18 measures will be taken, and therefore, an exchangeable correlation structure will be used to model the correlation among the measures from the same patient. Giving the exploratory nature of the study, will not adjust for the multiple comparisons. Pathologic responses and imaging measurements will be summarized using point estimates, and 95% confidence interval as well, for each of the four imaging modalities.

Pre-radiation therapy and post-radiation therapy 18F-DOPA PET activity will be correlated with pathologic response. The correlation between imaging measures and pathologic response will be evaluated using a logistic regression model for each one of the four imaging modalities separately. For each subject, 12-18 measures will be taken, and therefore, an exchangeable correlation structure will be used to model the correlation among the measures from the same patient. Giving the exploratory nature of the study, will not adjust for the multiple comparisons. Pathologic responses and imaging measurements will be summarized using point estimates, and 95% confidence interval as well, for each of the four imaging modalities.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma	NCT02021604	Congenital Hype... Insulinoma	Fluorodopa F 18	- 18 Years	Cook Children's Health Care System
Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study	NCT05781321	Glioblastoma	Accelerated Hyp... Computed Tomogr... Fluorodopa F 18 Magnetic Resona... Positron Emissi... Quality-of-Life... Questionnaire A... Radiation Thera... Temozolomide Biospecimen Col...	18 Years -	Mayo Clinic
18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy	NCT03778294	Glioblastoma Malignant Gliom...	Computed Tomogr... Fluorodopa F 18 Magnetic Resona... Positron Emissi... Proton Beam Rad... Quality-of-Life... Questionnaire A... Temozolomide	65 Years -	Mayo Clinic
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma	NCT02021604	Congenital Hype... Insulinoma	Fluorodopa F 18	- 18 Years	Cook Children's Health Care System
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma	NCT02021604	Congenital Hype... Insulinoma	Fluorodopa F 18	- 18 Years	Cook Children's Health Care System
An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas	NCT05560009	Recurrent Soft ... Resectable Soft... Soft Tissue Sar...	Fluorodopa F 18 Magnetic Resona... Positron Emissi... Radiation Thera... Surgical Proced...	18 Years -	Mayo Clinic
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma	NCT02021604	Congenital Hype... Insulinoma	Fluorodopa F 18	- 18 Years	Cook Children's Health Care System

Spots Global Cancer Trial Database for fluorodopa f 18