Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Radiopharmaceuticals

All neuroendocrine cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with 3 MBq/kg (maximum 370 MBq) of 68Ga-DOTA-TATE. 45-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician.

Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.

68Ga-DOTA-TATE

Stéphanie Dubreuil

Éric Turcotte, MD

Éric E Turcotte, MD

This clinical trial is a pragmatic study aiming to evaluate the innocuity/safety profile of the PET radiotracer 68Ga-DOTA-TATE, and to establish the procedure as a routine standard-of-care diagnostic tool for all neuro-endocrine cancer patients. It is a single-center study, but with recruitment across all Canada. The trial is prospective, non-randomized, open-label and with no control group. The superiority of this procedure over the former standard-of-care (Octreoscan) was already established in previous and numerous studies across the world. As such, the current trial aims to gather data to further support the implementation of 68Ga-DOTA-TATE as the new standard-of-care for neuro-endocrine tumors (NET).

Neuroendocrine cancer patients, regardless of the primary tumor origin, are eligible. Recruitment is across all Canada but the examination is performed at the primary site of the study. The safety profile of the procedure will be assessed, and integration of 68Ga-DOTA-TATE will be integrated in the routine clinical practice.

68Ga-DOTA-TATE PET/CT Imaging in NETs

Pragmatic Study on the Use of 68Ga-DOTA-TATE PET|CT Imaging as a Standard of Care to Influence Clinical Management

Following the injection, the patient will be explicitly reminded of possible symptoms and undesirable events. The patient will be advised to inform the study personnel of the occurrence of any events, at the most opportune time. The patient will be instructed to call the local nuclear medicine study coordinator for any undesirable event that may occur for 48 hours after the PET/CT scan.

Safety will be assessed by compiling all reported adverse events. Adverse events reported by patients or observed by the investigator will be recorded in the patients' CRFs, the AE database, and reported to the research manager.

Neuroendocrine tumors (NET) used to be difficult to diagnose early with conventional methods, but with the advent of new-generation Somatostatin Receptor radioligands such as 68Ga-DOTA-TATE precise and early detection is now frequent. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of NET patients on a large, nation-wide cohort. As such, the research team will monitor the clinical gain of 68Ga-DOTA-TATE on the diagnostic and management of NETs regarding sensitivity, specificity and accuracy compared to previous diagnostic methods.

Clinical and scientific evidences showed that 68Ga-DOTA-TATE is vastly superior as a diagnostic tool than the current standard-of-care Octreoscan. As such, this trial aims to implement 68Ga-DOTA-TATE as the new standard-of-care for precision diagnostic of NETs. In order to do so, health policy agencies (most notably Health Canada) will be notified about the gains (or the flaws if any) of 68Ga-DOTA-TATE over the current standard-of-care (Octreoscan) for the precise diagnostic and follow-up of NETs that will be observed during the present study. The safety profile and diagnostic accuracy assessed in Outcome 1 and 2 will be used to convince the authorities of the net benefit of using this procedure rather than the "old" standard-of-care.

Université de Sherbrooke

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Head of the clinical research, CIMS, CHUS

Gallium 68 PSMA-11

All cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with a \[68Ga\]-PSMA-617 dose calculated depending on the characteristics of the PET tomograph and patient weight (maximum 370 MBq). 60-90 minutes following injection, patients will be imaged in a PET/CT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.

The intervention consists of an intravenous injection of the radiopharmaceutical \[68Ga\]-PSMA-617 and a physiological saline flush, followed 60-90 minutes later by a PET/CT image acquisition.

[68Ga]-PSMA-617

Michel Paquette, PhD

This project aims to monitor the innocuity/safety profile of cyclotron-produced \[68Ga\]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for \[68Ga\]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.

This study also aims to instigate the use of \[68Ga\]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.

In developed countries such as Canada, prostate cancers are the most frequently diagnosed and the third deadliest cancer among men. Early detection and management of low-stage prostate cancer leads to a 5-year survival rate nearing 100%. However, advanced and metastatic prostate cancers remain a clinical challenge to both assess and treat, despite significant advances in the field in the last years.

Among the best existing diagnostic tools for advanced cancers overall, FDG-PET suffers from a very low sensitivity for prostate cancers. Indeed, not only those lesions are most of the time hypometabolic and indolent, but also loco regional assessment is heavily impaired by the proximity of the background-generating, radio metabolite-rich bladder. Other imaging modalities such as Computed Tomography (CT) and Magnetic Resonance imaging (MRI) do not perform better, and are also plagued with relatively low sensitivity and specificity. As such, alternative, PET tracers were developed in order to better assess metastatic prostate cancers. One of the earliest attempts was with choline-derived tracers (either labeled with 11C or 18F) which showed superior diagnostic properties than FDG, but still harbors a range of sensitivity from poor to excellent depending of the site of the lesions. Recently, the amino acid analog 18F-fluciclovine (Axumin) showed great promises thanks to a low renal excretion and high prostate tumor uptake which resulted in much improved sensitivity. However, while both choline and fluciclovine offer precise prostate cancer diagnostic, they do not provide much information about the prognostic of the disease or the efficacy of targeted therapies.

The Prostate Specific Membrane Antigen (PSMA) is a transmembrane glycoprotein with folate hydroxylase and glutamate carboxypeptidase enzymatic activities. PSMA was first reported to be strongly expressed in more than 90% of prostate cancers. Moreover, PSMA expression on prostate tumors is proportional to the plasmatic concentration of the routinely-assessed Prostate Specific Antigen (PSA), which is currently the main screening and treatment follow-up tool for prostate cancer. PSMA overexpression occurs most frequently in high-grade and metastatic diseases, as well as for castration-resistant cancers. As such, PSMA constitutes a target of choice for an imaging modality aiming for prognosis and treatment assessment of prostate cancers, as well as for targeted endoradiotherapy.

High PSMA expression was also observed in the neovasculature of most solid tumors, notably breast, lung and gastrointestinal cancers. 68Ga-PSMA-PET was reported to allow high-uptake detection of nonprostate cancers. More recently, a preliminary clinical report showed that breast cancers can readily be imaged using 68Ga-PSMA, with the highest detection rate observed in the triple-negative subtype. As such, while 68Ga-PSMA was mainly explored in prostate cancers until now, rising evidence demonstrates its applicability to most solid cancers as well.

In the last few years, many peptidomimetic compounds were designed as PSMA-specific ligands, such as PSMA-11, PSMA-617 and PSMA-1007. The latter is radiolabeled covalently with a 18F, whereas most other molecules depend upon their chelator moiety for labeling with a radiometal such as 64Cu or 68Ga. The main advantages of using a chelator-bearing compound include ease of labeling and purification along with the potential to alternatively label with therapeutic radiometals such as 177Lu or 225Ac to form a theranostic pair with PET-capable isotopes with the same molecular frame. Notably, PSMA-617, labeled with 68Ga for PET imaging and with 225Ac for therapy, showed astonishing potential in a cohort of advanced prostate cancer.

The current trial aim to investigate the use of cyclotron-produced 68Ga chelated in PSMA-617 for the diagnostic, prognostic and treatment follow-up of PSMA-overexpressing cancers. The relative performances and safety profile of the cyclotron-produced 68Ga-PSMA-617 at our center with the available clinical data from the literature. Moreover, the sensitivity, specificity and diagnostic performance of 68Ga-PSMA-617 will be compared with the current standard of care for PSMA+ cancer diagnostic and follow-up.

TUMORS THAT MAY BE VISUALIZED WITH 68GA-PSMA-617 PET/CT The sensitivity of 68Ga-PSMA-617 PET/ CT is likely to vary among tumor grade, PSA blood levels and depending on the density of PSMA in the tumors. PSMA is expressed by healthy prostate tissue, but at a baseline level compared to the overexpression assessed in prostate cancers. High PSMA levels were also reported in most glioma, lung, gastrointestinal, liver, breast, pancreatic and thyroid cancers, among others. As such, 68Ga-PSMA-617 is expected to enable precise detection and follow-up for all those indications.

High uptake is expected in the salivary glands; such foci should not be confounded with tumor lesions.

CLINICAL USES

In the management of cancers overexpressing PSMA, 68Ga-PSMA-617 PET/CT is recommended or under investigation for the following:

* Disease staging
* Follow-up of patients with known disease to detect residual, recurrent, or progressive disease (restaging)
* Determine PSMA status visually as well by using semi-quantitative parameters like standardized uptake value (SUV)
* Monitoring response to therapy

ELIMINATION ROUTE 68Ga-PSMA-617 is rapidly cleared from the blood. Arterial elimination of activity is bi-exponential, and no radioactive metabolites are detected after 12h in the serum or urine. 68Ga-PSMA-617 tumor uptake increases steadily through time. Excretion occurs via both the urinary and the hepatobiliary pathway.

68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study

Pragmatic Study on the Use of 68Ga-PSMA-617 PET/CT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA.

PSMA-PET is routinely used to assess and follow-up prostate cancers with unprecedented precision. Recent reports found that most solid cancers are also susceptible to be detected and managed with this modality. This trial offers the opportunity to evaluate the impact of this state-of-the-art diagnostic procedure on the management of eligible cancers patients on a large, nation-wide cohort.

Clinical and scientific evidences hinted that \[68Ga\]-PSMA-617 might be a complementary, even superior diagnostic tool than the current standard-of-care FDG-PET/CT for solid tumors. As such, this trial aims to implement \[68Ga\]-PSMA-617 as the new standard-of-care for precision diagnostic of NETs.

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Hematologic Neoplasms

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

PRIME is a decision support tool that uses best-worst scaling to provide a personalized report to providers and patients of their most important treatment priorities

Preference Reporting to Improve Management and Experience (PRIME)

Mireille L Leone

Daniel R Richardson,, MD, MA, MSc

Daniel R Richardson, MD, MA, MSc

The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.

In the last decade, remarkable advances in drug development have led to the approval of 52 new therapies for patients with hematologic malignancies. These new approvals are increasingly enabling clinicians to personalize chemotherapy decisions to achieve what matters most to patients. Therefore, accurately assessing patient preferences is critical to personalizing treatment decisions, particularly among older adults, who face high treatment-related morbidity and/or shorter anticipated survival.

Patient preferences have traditionally been inferred from face-to-face conversations. However, numerous studies, including several systematic reviews, have demonstrated that this process alone is inadequate to reliably capture patient preferences. To support standard shared decision making, multiple stakeholders strongly advocate the development of validated patient-reported measures that accurately capture patients' preferences. In recent guidance about the care of older adults with leukemia, the American Society of Hematology explicitly recommends the development of novel decision support tools to address this growing challenge in patient-centered care. Improved shared decision making has been associated with increased patient-reported quality of care and satisfaction, and a reduction in healthcare utilization.

This study will determine the effectiveness of a novel decision support tool called "PRIME" (Preference Reporting to Improve Management and Experience) to improve the values-concordance of initial treatment decisions. Using best-worst scaling, a validated values-elicitation method, PRIME provides a personalized report to providers and patients of their most important treatment priorities.

In this pragmatic trial, participants will be randomized to receive decision support with PRIME or usual care prior to their first visit with their oncologist. The primary outcome will be clinically significant improvement in values-concordance of the initial treatment decision (on CollaboRATE, a validated 12-point measure).

DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics

The effectiveness of PRIME to improve the value-concordance of treatment decisions in older subjects presenting to hematologic malignancy clinics will be determined by differences in CollaboRATE scores (Percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups.

COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.

The secondary outcome will be the difference in CollaboRATE scores (percentage in each arm that report perfect scores 15/15) at the post-treatment decision assessment between control and intervention groups in a subgroup of participants: participants with newly-diagnosed Acute myeloid leukemia, Acute Lymphoblastic leukemia, Diffuse Large B-cell Lymphoma, and Multiple myeloma COLLABORATE scores is a Likert scale questionnaire that includes 3 questions rated from 1 to 5. Higher scores represent better patient engagement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
68Ga-DOTA-TATE PET/CT Imaging in NETs	NCT04847505	Neuroendocrine ...	68Ga-DOTA-TATE	-	Centre de recherche du Centre hospitalier universitaire de Sherbrooke
68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study	NCT05228106	Solid Cancers	[68Ga]-PSMA-617	-	Centre de recherche du Centre hospitalier universitaire de Sherbrooke
DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics	NCT06296368	Hematologic Mal... Lymphoma Multiple Myelom... Leukemia Blood Cancers	Preference Repo...	60 Years -	UNC Lineberger Comprehensive Cancer Center
68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study	NCT05228106	Solid Cancers	[68Ga]-PSMA-617	-	Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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