NCT07702292

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
18mo left

Started Jun 2026

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Feb 2028

First Submitted

Initial submission to the registry

June 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

June 30, 2026

Last Update Submit

July 14, 2026

Conditions

Colorectal CancerEpithelial Ovarian CancerGastric Cancer (GC)Pancreatic Ductal Adenocarcinoma (PDAC)Invasive Lobular Breast Carcinoma

Keywords

Positron emission tomographyFibroblast activation protein

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Further assess the diagnostic performance of [68Ga]BED003.

    Until completion of follow-up procedures, up to 42 days post injection

  • Semiquantitative assessment of [68Ga]BED003 tumour uptake.

    Immediately following administration of [68Ga]BED003

  • Evaluate the safety and tolerability of [68Ga]BED003.

    From screening until safety follow-up (48 hours post injection).

  • Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants).

    Immediately following administration of [68Ga]BED003

  • Confirm optimal [68Ga]BED003 administered activity (first 6 participants).

    Immediately following administration of [68Ga]BED003

Study Arms (1)

[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).

Drug: [68Ga]BED003

Interventions

[68Ga]BED003DRUG

Positron emission tomography (PET)/computed tomography (CT) imaging

[68Ga]BED003

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.
  • Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.
  • Suspected recurrence after definitive therapy.

You may not qualify if:

  • 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:
  • Any other primary cancers that could confound the interpretation of the study results.
  • Major surgery (such as laparoscopy/laparotomy/thoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Active hepatitis.
  • Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

Roma, Roma, 00136, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, Segrate, 20132, Italy

RECRUITING

University Medical Center Groningen

Groningen, 9713, Netherlands

RECRUITING

Stichting Radboud Universitair Medisch Centrum

Nijmegen, 6525, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinoma, Ovarian EpithelialStomach NeoplasmsCarcinoma, Lobular

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersStomach DiseasesAdenocarcinomaNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jamie MacKay

CONTACT

44 (0)1865 507300contact@blueearthdx.com

Jason Kane

CONTACT

44 (0)1865 507300contact@blueearthdx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 14, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

IT(4)NL(2)