Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

1. Diagnostic pelvic CT
2. Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation
3. CT simulation (2 hours after prostate markers are placed)
4. SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection)

Single Photon Emission Computed Tomography (SPECT)

Jeff Michalski, M.D.

The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.

Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.

The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal

Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer

Safety: The study will be feasible if no more than 80% of patients experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction to Tc99.

Efficacy: The study will be feasible if at least 80% of patients have at least one identifiable lymph node on SPECT-LM.

1. Greatest radial distance of lymphatic channel volume from vessel wall contour
2. Fraction of lymphatic channel volume, normal tissue volume, and critical structure volumes included in radial expansions from vessel wall

Washington University School of Medicine

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The subject will receive f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.

Lymphoseek

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

Indocyanine Green (ICG)

Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.

Neoprobe Gamma Detection System NPB11L(Model1102)

Amer K Karam, MD

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green.

Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.

Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study

A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device.

For each subject, an assessment will be made of whether there was overall sentinel node detection. A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device. If at least one SLN is detected (on any side), then this outcome will be considered a 'Yes'.

The number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device.

The location and number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device.

Number of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device.

Location of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device.

Stanford University

Clinical Professor

Participants received f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) was injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes were visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images helped guide the surgery.

Lymphoseek/SPECT-CT/Indocyanine

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Endometrioid Grade 1

Endometrioid Grade 2

Low-grade endometrioid carcinomas (EECs) grade is based on the proportion of solid areas: low grade = grade 1 (≤5%) and grade 2 (6%-50%); and high grade = grade 3 (\>50%).

Histology

This study did not meet its planned enrollment and did not achieve statistical power.

Amer Karam, MD

Number of Participants With Bilateral SLNs

Overall Detection of SLN Detection

Number of SLNs Detected by Lymphoseek:

Data are not available as no SLNs were detected using Lymphseek

Location of SLNs Detected by Lymphoseek:

Number of SLNs Detected by Indocyanine Green

Common Iliac

External Iliac

Hypogastric

Obturator

Right-Sided SLN Locations

Left-Sided SLN Locations

Location of SLNs Detected by Indocyanine Green

Overall Study

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Oculocerebral Syndrome With Hypopigmentation

Neuroendocrine Tumor

Neuroepithelioma

Radiopharmaceuticals

Participants randomized to this arm will receive imaging agent \[203Pb\]VMT01 and undergo SPECT/CT imaging first. Later, participants in this arm will receive \[68Ga\]VMT02 and undergo PET/CT imaging.

Participants randomized to this arm will receive imaging agent \[68Ga\]VMT02 and undergo PET/CT imaging first. Later, participants in this arm will receive \[203Pb\]VMT01 and undergo SPECT/CT imaging.

Diagnostic imaging radiopharmaceutical; by intravenous infusion

[203Pb]VMT01

[68Ga]VMT02

Frances L Johnson, MD

Geoffrey B Johnson, MD, PhD

The study hypothesis is that new imaging agents \[203Pb\]VMT01 and \[68Ga\]VMT02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor (MC1R) by SPECT/CT and PET/CT imaging modalities respectively.

This is a first-in-human study evaluating the suitability of \[203Pb\]VMT01 for SPECT/CT imaging and \[68Ga\]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Study results will provide foundational data to develop imaging and dosing for future therapeutic trials of \[212Pb\]VMT01 for the treatment of metastatic melanoma.

The study will be a cross-over study with the participants serving as their own comparator. Participants with positive FDG-PET scans for stage IV (or inoperable stage III) metastatic melanoma will undergo SPECT/CT scans utilizing \[203Pb\]VMT01 followed a few weeks later by PET/CT scans utilizing \[68Ga\]VMT02, or vice versa. The order of the imaging agents will be randomly assigned.

Archived tumor tissue will be tested for expression of the imaging target, melanocortin receptor sub-type 1 (MC1R). The qualified researcher who tests the sample, and the independent pathologist who reviews the results, will be blinded to a participant's identifying information and imaging results. Evaluators will not have access to the medical record.

A pool of three qualified readers will evaluate study images (PET/CT and SPECT/CT). Images and medical information given to the readers will not include a participant's identifying information. The reader pool will not know the sequence of imaging for a participant or have access to the medical record.

An independent medical physicist will validate imaging results and measurements of radiation absorbed and excreted by the participant's body. The physicist will be blinded to participant identifiers and demographics, as well as the sequence of imaging for a participant. The physicist will not have access to the medical record.

Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

A Phase 1 Cross-over Biodistribution Study of [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) Imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) Imaging of Stage IV Metastatic Melanoma

All de-identified individual participant data (IPD) that underlies results in a peer-reviewed scientific publication will be shared.

Adverse Events (AEs) will be assessed for severity according to CTCAE v5.0 and for relatedness to each of the investigative imaging agents (\[203Pb\]VMT01 and \[68Ga\]VMT02). Assessments attributed as possibly, probably, or definitely related to the imaging agent will be considered related.

Biodistribution will be calculated by utilizing PET/CT scans.

Biodistribution will be calculated by utilizing SPECT/CT scans.

Cmax will be determined by blood sampling and direct radioactivity measurements.

AUC will be determined by blood sampling and direct radioactivity measurements.

Renal excretion will be determined by urine sampling and direct radioactivity measurements.

Dosimetry will be modeled by utilizing the SPECT/CT scans.

Archived (previously collected) tumor tissue will be tested for MC1R expression and compared to study images obtained using MC1R targeted imaging agents, \[203Pb\]VMT01 and \[68Ga\]VMT02. The data will be assessed for an association between positive tissue and positive images.

Sites of cancer detected previously by imaging will be compared to the presence or absence of positive imaging scans with the study agents, \[203Pb\]VMT01 and \[68Ga\]VMT02.

For a given participant, dosimetry calculations will be compared between the two imaging agents with respect to cumulative absorbed dose of radiation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping	NCT00608920	Adenocarcinoma ...	Single Photon E...	18 Years -	Washington University School of Medicine
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer	NCT04511026	Endometrial Can...	Lymphoseek Single Photon E... Indocyanine Gre... Neoprobe Gamma ...	18 Years -	Stanford University
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy	NCT04904120	Melanoma (Skin) Melanoma Stage ... Melanoma, Uveal Melanoma, Mucos...	[203Pb]VMT01 [68Ga]VMT02	18 Years - 89 Years	Perspective Therapeutics

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