Adana, Nigeria

68Ga-PSMA PET Imaging of Upper Metastatic Gastric Cancers to Determine Eligibility to Endoradiotherapy

Background: Upper gastrointestinal (GI) cancers are a major health problem in Canada. At the metastatic stage, options are limited (usually chemotherapy, immunotherapy, personalized therapies under research protocols). These options are not applicable to all patients and may have significant toxicities. Endoradiotherapy (ERT) using a radioisotope coupled with a localization vector specifically targeting tumor cells to deliver a localized dose of radiation therapy is a promising avenue as it can treat disseminated neoplastic disease in a specific manner sparing healthy tissue with minimal side effects. 177Lu-PSMA would be a potentially usable ERT agent for upper GI cancers. Initially developed for prostate cancer, for which it has been successfully proven, it targets the PSMA protein found on tumor cells or their microenvironment. Its localization is usually confirmed by imaging with 68Ga-PSMA, which is the other component of its theranostic pair. There are many case reports showing significant accumulation of 68Ga-PSMA in upper GI cancers, but there are no prospective studies to determine with certainty whether these are isolated cases or whether these tumors consistently uptake this agent; the same uptake that determines whether 177Lu-PSMA ERT has potential efficacy for these patients. We believe that 177Lu-PSMA ERT could provide an effective radiation dose to treat metastatic high-grade GI cancers without exceeding acceptable dose limits to healthy tissue, providing a new therapeutic avenue for this patient group. Objective: 1. To confirm that patients with upper gastric cancers would be eligible for 177Lu-PSMA treatment by using 68Ga-PSMA PET/CT assessment, according to the criteria suggested by the European Association of Nuclear Medicine (EANM) (tumor uptake 1.5 times higher than the liver) 2. Determine tumor heterogeneity (proportion of tumor lesions identified by computed tomography (CT) that capture 68Ga-PSMA) in each patient; 3. Determine the proportion of patients with lesions that do not accumulate 68Ga-PSMA; 4. Calculate the pharmacokinetics of 68Ga-PSMA by serial PET imaging; 5. Calculate dosimetry of healthy and tumor tissues; Study population: Adults with upper metastatic gastric cancer (adenocarcinomas of the esophagus, stomach, bile ducts and pancreas) Procedure and Follow-up: Patient will undergo 68Ga-PSMA PET imaging at different post-injection times (total visit duration of approximately half a day). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.

68Ga-DOTATATE Neuroblastoma Imaging Pilot

Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy. Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG. Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant. Study population: Children and adults with biopsy-proven or suspected neuroblastoma Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.

Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer

Entire-body PET Scans for Multiple Sclerosis

To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.

iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine

Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer

The study goal is to evaluate combined radioactive iodine (RAI, 131-I) and external beam radiotherapy (XRT) to optimize the radiation dose delivered to treat well-differentiated thyroid cancers (DTC) with iodine-avid metastases, hypothesizing that this combination approach is safe and enables delivery of higher local radiation doses than could otherwise be safely delivered with either radiotherapeutic modality alone. This is an open-labeled, phase 1 clinical trial design that will enroll study subjects with recurrent DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and/or non-resectable distant metastases. Study subjects will have a sub-therapeutic level of lesional RAI uptake demonstrated in either a pre-treatment diagnostic scan or a previous post-treatment radioiodine scan, making it unlikely that the patient would fully benefit from RAI therapy alone. The primary objective is evaluate safety as defined by the incidence of maximum grade 3 or greater NCI CTCAE grade toxicity observed during the treatment period and for the first 30 days following completion of radiotherapy. Additional secondary endpoints will evaluate efficacy at 6 months and feasibility of this combination to deliver a minimum cumulative dose of 80 Gy (66 Gy, Equivalent dose in 2Gy fractions (EQD2); 2 Gy per fraction) to the index tumors (up to 3 in each study subject) selected prior to treatment initiation. The investigators plan to enroll 48 subjects at an accrual rate of 1 subject per month over a study duration of 4 years.

FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary

Cancers of unknown primary (CUP) account for 3-5% of all malignancies. The prognosis of patients diagnosed with CUP is poor, with a median overall survival of 9-12 months. Despite improvements in conventional diagnostic processes, the tissue of origin (ToO) is identified in <30% of CUP patients. PET/CT is increasingly used to determine the ToO, with the most commonly used PET radiotracer being the glucose analogue fluorine-18 fluorodeoxyglucose (FDG). Although PET/CT can change CUP patient management and identify primary sites, FDG has limited sensitivity for detecting some cancers, such as CUP. It has been reported that fibroblast activation protein (FAP) is highly expressed in some tumours, including CUP. 68Ga-FAPI (experimental drug) is a radiotracer that can specifically bind to FAP, and may enable the primary cancer site to be viewed using PET imaging. It is hypothesised that the use of 68Ga-FAPI-PET/CT will increase likely ToO diagnosis from 30% with current standard of care to 60%.

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

The study includes screening period, treatment period, and a post-treatment follow-up period. Screening Period: Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617. Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review. Treatment Period: Eligible participants will be treated with up to 12 cycles of 7.4 GBq AAA617 intravenously every 6 weeks, until radiographic progression, toxicity leading to treatment discontinuation, death, loss to follow-up, or withdrawal of consent, whichever occurs first. During treatment period, all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles. Post-Treatment Follow-Up: All participants will undergo a PSMA-PET scan at end of treatment (EOT). The post-treatment follow-up period will consist of EOT; 42-days safety; EOT RLI; safety, survival and rPFS follow-up visits. The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks. Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression, and/or at the discretion of the Investigator or the participant.

Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors

Research Design This study is a prospective, single-center, non-randomized study evaluating the role of primary endoscopic SLNB on progression-free survival in patients with stage I-II germ cell seminoma/non-seminoma tumor without adjuvant treatment. Additionally, the study will determine the prognostic value of miRNAs as a noninvasive marker in clinical practice. This study plans to recruit 44 male patients with a preliminary diagnosis of testicular tumor. Patients who meet the inclusion/exclusion criteria will undergo surgical treatment including orchofuniculectomy with a simultaneous assessment and biopsy of the sentinel retroperitoneal lymph node. The first stage of treatment Pre-operative preparation At the preoperative stage, it is planned to perform 3D modeling of computed tomography slices to visualize tumor conglomerates and vascular topography. A map of lymph node dissection zones will also be compiled. The anatomical boundaries of lymph node dissection are the aorta, the inferior vena cava, the iliac vessels, their bifurcation zones, the renal and mesenteric vessels. Due to the distribution of lymph nodes into cohorts (from 1 to 9 in each case), further histological examination of the surgical material will assess the completeness of the performed lymph node dissection. Radiopharmaceutical administration (Technetium/methylene blue) 24 hours before surgery, a radiotracer (RP) will be injected into the spermatic cord followed by SPECT to identify the regional sentinel lymph node(s). Orchofuniculectomy Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach. After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump. Second stage of treatment Laparoscopic access and port placement Under general anesthesia, with the patient in the supine position with arms extended along the body and legs spread apart, after processing the surgical field, laparoscopic ports will be installed under sterile conditions as follows: - In the pubic region, 1 cm below the navel, an optical trocar is installed according to the Hasson technique (pneumoperitoneum (P=14 mmHg). - Installation of trocars in the right iliac region, in the left iliac region and above the pubic symphysis (5, 5 and 11 mm, respectively). The patient is then placed in the Trendelenburg position. BSLU Next, in the operating room, the surgeon will use a gamma detector to determine the location of the sentinel lymph nodes, followed by removal of one or more (up to 4) lymph nodes from which the signal is received. These lymph nodes will be sent for histological examination. The results of the work performed will present indicators of relapse-free survival after SLNB, as well as functional outcomes, such as postoperative complications, duration of hospital treatment, frequency of retrograde ejaculation in patients with stage IA-IIA testicular germ cell tumor. The data obtained will allow optimizing the selection of patients for surgical treatment, as well as identifying prognostic factors for the adjuvant stage of therapy. Additionally, as part of the work, it is planned to study the expression profile of microRNAs in blood plasma, with subsequent assessment as a potential prognostic and predictive factor in patients with germ cell tumors. For this purpose, blood will be drawn from patients before surgery and 10 days after surgery.