Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

Angiogram

Undergo prostatic arterial catheterization

Catheterization

Gallium Ga-labeled PSMA-11

Positron Emission Tomography

Ryan Kohlbrenner

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

PRIMARY OBJECTIVE:

I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

SECONDARY OBJECTIVES:

I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves \[TACs\] ipsilateral to the side of infusion).

OUTLINE:

Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients

A two-sided paired t-test will determine whether the ipsilateral SUVmax values obtained during selective arterial 68Ga-PSMA-11 infusions are greater than those obtained during venous infusions. A similar paired analysis will be made during arterial infusions to compare tumoral regions of interest (ROIs) ipsilateral and contralateral to the side of the infusion. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether SUVmean is different for intra-arterial (IA) time activity curves (TACs) when compared to intravenous (IV) TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether TSUV is different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether AUCs are different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

To assess whether the rate of uptake is significantly different with selective arterial infusion, a two-sided paired t-test will compare the slopes for Selective arterial infusion, tumor ipsilateral to the side of radiotracer injection (IAIpsi) curves and Intravenous infusion, tumor ipsilateral to the side of corresponding arterial injection (IVIpsi) curves during each of the nine time intervals. Selective arterial infusion, tumor contralateral to the side of radiotracer injection (IACont) slopes will be similarly compared to those acquired from corresponding Intravenous infusion, tumor contralateral to the side of corresponding arterial injection (IVCont) data. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Specific to the IAIpsi TACs, the time to early saturation effects (Tese) will represent the time at which the second derivative of the curve becomes negative (i.e. when concavity in the curve is first noted). For the purposes of Tese, the aforementioned curve partitioning method will not be used. Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

The mean SUVwashout and its standard deviation will be calculated for the 15-minute post-injection periods.

Radiological Society of North America

Ryan Kohlbrenner, MD

Principal Investigator

Rare Diseases

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients undergo radioembolization with TheraSphere given intra-arterially. Patients undergo angiogram during screening, SPECT scan on study and CT scan and blood sample collection throughout the study.

Biospecimen Collection

Computed Tomography

Radioembolization

Single Photon Emission Computed Tomography

Survey Administration

Yttrium Y 90 Glass Microspheres

Arshia Mian

Saima Chaabane

Arshia A. Mian

Siddharth A. Padia, MD

Siddharth A Padia

This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.

PRIMARY OBJECTIVE:

I. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC).

SECONDARY OBJECTIVES:

I. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria.

II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C.

V. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire.

OUTLINE:

Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months.

Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial

RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial

According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson.

According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology.

According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.

Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C.

Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.

Will be summarized using descriptive summaries.

Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome.

Change in overall quality of life based on patient-reported outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion	NCT04976257	Prostate Adenoc... Prostate Carcin... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Angiogram Catheterization Gallium Ga-labe... Positron Emissi...	18 Years - 80 Years	University of California, San Francisco
Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial	NCT06432036	Stage I Renal C... Stage II Renal ...	Angiogram Biospecimen Col... Computed Tomogr... Radioembolizati... Single Photon E... Survey Administ... Yttrium Y 90 Gl...	18 Years -	Jonsson Comprehensive Cancer Center
Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial	NCT06432036	Stage I Renal C... Stage II Renal ...	Angiogram Biospecimen Col... Computed Tomogr... Radioembolizati... Single Photon E... Survey Administ... Yttrium Y 90 Gl...	18 Years -	Jonsson Comprehensive Cancer Center

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Spots Global Cancer Trial Database for angiogram

Every month we try and update this database with for angiogram cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for angiogram cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.