Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

18F-PSMA-1007 PET tracer

This is a pilot study to determine uptake of PET tracer 18F-PSMA-1007 in primary glioblastoma.

Glioblastoma multiforme (GBM) is a highly vascularised tumour. Previous studies have shown that prostate-specific membrane antigen (PSMA) is robustly expressed by the tumour vascular endothelium of GBM and thus could be an interesting target for diagnosis and treatment.

Several groups have focused on the development of 18F-labeled PSMA ligands for PET imaging. 18F as a radionuclide has several advantages over 68Ga. Due to the longer half-life compared (110 min for 18F compared to 68 min for 68Ga) allows for centralized production and distribution to greater areas. Furthermore, multiple doses of 18F can be produced in one synthesis, while each gallium generator provides only one or two elutions per day. Moreover, due to the decreased positron energy (0.65 MeV for 18F compared to 1.90 MeV for 68Ga) imaging resolution may be higher. The first generation of 18F-PSMA ligands, such as 18F-DCFBC, suffered from high background due to slow blood clearance. The second generation 18F-DCFPyL PSMA ligand has a fast elimination via the urinary route and showed high tumor-to-blood ratios. Benesova et al developed the 177Lu-DKFZ-61, which is suitable for labelling with both diagnostic 68Ga as well as therapeutic 177Lu (beta-emitting) or 225Ac (alpha-emitting), and Giesel at al developed 18F-PSMA-1007, which is structurally related to DKZF-617.

Since various studies have shown feasibility of PSMA imaging in brain lesions of patients with recurrent GBM, we want to extend these results in a cohort of patients with a first-diagnosed suspected GBM. We want to use the PET tracer 18F-PSMA-1007. If this technique can be implemented successfully, the added value of 18F-PSMA PET/CT for tumour grading and differential diagnosis could be investigated further in larger patient cohorts (especially with recurrent brain lesions). These studies will pave the way for further studies involving 177Lu-PSMA-based therapy, which is currently applied in patients with metastatic prostate cancer.

18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme

Radboud University Medical Center

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anticoagulants

All Drugs and Chemicals

Micronutrients

Other Dietary Supplements

Citric Acid

Sodium Citrate

Edetic Acid

Pentetic Acid

Gallium citrate

Chelating Agents

Antidotes

Protective Agents

Iron

Iron Chelating Agents

Radiopharmaceuticals

Citrate

Ga-67 citrate injection alone for individuals with cancer cells in cerebral spinal fluid (CSF), no earlier treatment for disease.

Ga-67 + In 111 DTPA injection for individuals who have cancer cells in CSF, no earlier treatment for disease.

Individuals with tumors in the CSF that have been treated and are now cleared from the CSF, receive standard follow-up care (baseline injection of Ga-67 citrate and In-111 DTPA).

Group A: Ga-67 citrate injection alone, in the baseline study.

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

Gallium-67 Citrate (Ga-67)

Group B: Ga-67 and In 111 DTPA injection in the baseline study.

Group C: Standard of care with Ga-67 and In 111 DTPA injection in baseline study.

In-111 DTPA (In-111 pentetate)

Franklin C Wong, M.D.

* Primary Objective will be to evaluate the use of Ga-67 citrate as an alternative radiopharmaceutical for CSF imaging.
* Secondary Objective will be to evaluate the biodistribution, pharmacokinetics and radiation dosimetry of In 111 DTPA and gallium-67 after intrathecal injection during remission of leptomeningeal metastasis (LM) and during LM occurrence, remission and recurrence.

In-111 DTPA is a radioactive dye that is standardly used to check the flow of CSF. Ga-67 citrate has been used to detect inflammation and tumors in other parts of the body, and researchers want to learn if it is also able to detect tumors in the brain and spinal cord.

Before you can be enrolled in this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1-2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.

If you are found to be eligible to take part in this study, you will be assigned to 1 of 3 groups. The group you are assigned to will depend on whether tumor cells were found in the CSF during your last spinal fluid exam. If you were found to have cancer cells in the CSF and you have had no earlier treatment for this type of disease, the first 5 participants will be assigned to Group A and will be given Ga-67 citrate injection alone, in the baseline study. The next 5 participants who have cancer cells in the CSF and have had no earlier treatment will be assigned to Group B. Group B will have Ga-67 and In 111 DTPA injection in the baseline study. Otherwise, if the tumors in the CSF have been treated and are now cleared from the CSF, you will be assigned to Group C and will receive standard follow-up care.

At the beginning of the study, you will have an imaging session. This first imaging session is called the "baseline" session. For the imaging, you will lie on a gamma camera table. Depending on which group you are in, one or both of the radioactive dyes will be injected into your CSF through the Ommaya reservoir. If you are in Group B or C, both In-111 DTPA and Ga-67 citrate will be injected over about 2-4 minutes, total. If you are in Group A, Ga-67 citrate alone will be injected over about 2 minutes.

For participants who are 2-17 years old, the doses of In-111 DTPA and Ga-67 citrate will be adjusted to the surface area of your body (a measurement of your body size).

During the hour immediately following the injections, your head, neck, and back areas will be imaged (scanned) in order to see how the CSF flows. After that, you will have scans of your entire body performed in order to see how quickly the radioactive dyes leave from different parts of your body. These whole-body scans will each last 20 minutes. These scans (1 each time) will occur at 1-2, 3-4, 6-8, 22-24, 28-32, 48, and 72 hours after the injections. You will have blood samples collected before injection and during each imaging session in order to measure how much radiation is absorbed by different parts of your brain, spine, and other organs. These blood samples (less than ¼ teaspoon each time) will be drawn during each of the whole-body scans.

If you are in Group A or B, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. This is in order to check the status of the disease. If the cancer goes into remission (no tumor cells are found in CSF) at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and/or Ga-67 citrate injections as the baseline imaging session.

If you are in Group C, you will receive standard follow-up care for up to 52 weeks after the baseline imaging session. If the cancer reappears at any time during the 52 weeks, you will have a follow-up imaging session. The follow-up imaging session will include the same procedures, and In-111 DTPA and Ga-67 citrate injections as the baseline imaging session.

Whether you are in Group A, B or C, after your last follow-up imaging session, your participation in this study will be over. If your cancer clears from the spinal fluid, the records from your routine visit to the neuro-oncology clinic will be reviewed to follow your progress until 30 days after the radioisotope injection for your last imaging session. Researchers will review your medical records for potential side effects. If you do not have a clinical visit within a week from that 30th day, the study chair will contact you by phone concerning these matters.

This is an investigational study. In-111 DTPA is commercially available and FDA approved for injection into the CSF. Although Ga-67 citrate is FDA approved for injection into a vein, it is not FDA approved for injection into the CSF. It is commercially available, but injecting it into the CSF has only been authorized for use in research. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.

Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA

Phase 1 Study Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Renal Cell Carcinoma

Technetium Tc 99m Sestamibi

Gopal N Gupta, MD

Agnes Natonton

Hiten D Patel, MD, MPH

The goal of this clinical trial is to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor.

The main objectives are:

To estimate and compare the diagnostic accuracy of renal mass biopsy alone, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate malignant and benign renal tumors.

To estimate and compare the diagnostic accuracy of renal mass biopsy, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate oncocytoma from chromophobe RCC.

Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. These can be done on paper, electronically, or by telephone.

The investigators are asking the participant to take part in this research study because they were diagnosed with a kidney tumor. Kidney tumors can be benign (not cancer) or malignant (cancer) and the investigators hope to figure out how to better tell them apart before surgery or other treatment.

The investigators hope to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor.

Biopsy is a standard test to determine if a tumor is cancerous before making a treatment decision.

The imaging test (99mTc-sestamibi SPECT/CT) the investigators are studying has been studied before and found to help identify benign kidney tumors. It is not approved by the Food and Drug Administration (FDA) for imaging kidney tumors. It is FDA approved for use in imaging the heart and breasts. It has been studied for use in parathyroid gland imaging.

The participant will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. The participant will receive a 99mTc-sestamibi SPECT/CT scan (if they have not had one already) for research purposes. The participant will receive a biopsy of the kidney tumor (if they have not had one already) as part of their routine clinical care. The participant will then receive treatment of the kidney tumor as determined by consultation with their doctor.

Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

The classification of each tumor as malignant or benign by the diagnostic approaches of interest will be compared to the primary endpoint of malignant vs. benign based on surgical pathology or biopsy.

The classification of each tumor as RCC or oncocytoma by the diagnostic approaches of interest will be compared to the primary endpoint of RCC vs. oncocytoma based on surgical pathology or biopsy.

To estimate the non-diagnostic rate of renal mass biopsy.

To describe patient-reported measures/outcomes related to mental health, physical health, distress, and regret for the diagnosis and management of renal tumors.

Loyola University

Affiliate Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme	NCT04588454	Glioblastoma Mu...	18F-PSMA-1007 P...	18 Years -	Radboud University Medical Center
Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA	NCT00477503	Central Nervous... Brain Tumors	Gallium-67 Citr... In-111 DTPA (In...	2 Years -	M.D. Anderson Cancer Center
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors	NCT05728957	Kidney Tumor Renal Benign Ne... Renal Malignant...		18 Years -	Loyola University
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors	NCT05728957	Kidney Tumor Renal Benign Ne... Renal Malignant...		18 Years -	Loyola University
Nuclear Imaging of Human CSF Flow Using Ga-67 Citrate and In-111 DTPA	NCT00477503	Central Nervous... Brain Tumors	Gallium-67 Citr... In-111 DTPA (In...	2 Years -	M.D. Anderson Cancer Center

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