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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP 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 |
|---|---|---|---|
| [18F]FPyQCP PET/CT | Experimental | Each participant will receive [18F]FPyQCP 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 |
|---|---|---|---|---|
| [18F]FPyQCP | Drug | positron emission tomography (PET)/computed tomography (CT) imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess radiation dosimetry of [18F]FPyQCP (Cohort A) | Whole body effective dose of a single dose of [18F]FPyQCP | Up to 360 minutes post injection |
| Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B) | Sensitivity and specificity of [18F]FPyQCP PET/CT compared to composite standard of truth | Until completion of follow-up procedures, up to 42 days post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts) | Purpose is to evaluate the safety and tolerability of [18F]FPyQCP | From screening until safety follow-up (48 hours post injection) |
| Further assess the diagnostic performance of [18F]FPyQCP (Cohort B). |
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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.
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).
Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [18F]FPyQCP administration.
WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease [5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of [18F]FPyQCP administration.
Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before [18F]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
Either:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie MacKay, MD, PhD | Contact | +447350456887 | jamie.mackay@blueearthdx.com | |
| Evgenia Perkins | Contact | +19139576499 | evgenia.perkins@blueearthdx.com |
| Name | Affiliation | Role |
|---|---|---|
| Steven Rowe, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [18F]FPyQCP 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 |
| 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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