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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521983-36-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]BED003 | Experimental | Each participant will receive [68Ga]BED003 followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]BED003 | Drug | Positron emission tomography (PET)/computed tomography (CT) imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the diagnostic performance of [68Ga]BED003 in the peritoneum. | Assess the diagnostic performance of [68Ga]BED003 in the peritoneum. | Until completion of follow-up procedures, up to 42 days post injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Further assess the diagnostic performance of [68Ga]BED003. | Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [68Ga]BED003 PET/CT compared to composite SOT and participant and region level detection rates | Until completion of follow-up procedures, up to 42 days post injection |
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Inclusion Criteria:
Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
Eastern Cooperative Oncology Group performance status ≤ 2.
Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [68Ga]BED003 administration.
Note: If combining screening (Visit 1) and the PET/CT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.
WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).
Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
Note: Invasive breast cancer with mixed ductal/lobular histology is permitted.
Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before [68Ga]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
Either:
Exclusion Criteria:
Participants administered any radioisotope within 5 physical half-lives prior to [68Ga]BED003 administration.
Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
Participants who have recently received any other contrast agent (< 24 hours for IV agents and < 5 days for oral agents) before the day of [68Ga]BED003 administration.
Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
Known hypersensitivity to [68Ga]BED003 or any of its constituents.
Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion, including, but not limited to, the following:
Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer (e.g. tumour-associated pancreatitis or biliary stasis for PDAC).
Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
Significant renal impairment, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL/min/1.73m2 or a serum creatinine > 1.5 × the upper limit of normal.
Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie MacKay | Contact | 44 (0)1865 507300 | contact@blueearthdx.com | |
| Jason Kane | Contact | 44 (0)1865 507300 | contact@blueearthdx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Recruiting | Bergamo | Lombardy | 24127 | Italy |
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| Semiquantitative assessment of [68Ga]BED003 tumour uptake. | Standardised uptake values and tumour-to-background ratios. | Immediately following administration of [68Ga]BED003 |
| Evaluate the safety and tolerability of [68Ga]BED003. | Incidence and severity of adverse events using CTCAE version 5.0. | From screening until safety follow-up (48 hours post injection). |
| Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants). | Comparison of tumour-to-background ratios and reader assessments of diagnostic quality. | Immediately following administration of [68Ga]BED003 |
| Confirm optimal [68Ga]BED003 administered activity (first 6 participants). | Reader assessments of diagnostic quality based on simulated reduced count data. | Immediately following administration of [68Ga]BED003 |
| Fondazione IRCCS San Gerardo dei Tintori | Not yet recruiting | Monza | Lombardy | 20900 | Italy |
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| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Not yet recruiting | Roma | Roma | 00136 | Italy |
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| IRCCS Ospedale San Raffaele | Recruiting | Milan | Segrate | 20132 | Italy |
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| University Medical Center Groningen | Recruiting | Groningen | 9713 | Netherlands |
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| Stichting Radboud Universitair Medisch Centrum | Recruiting | Nijmegen | 6525 | Netherlands |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D013274 | Stomach Neoplasms |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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