FARE Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

24 Mar 2025 → ongoing

Decision date (initial)

2023-11-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Cancer Center Amsterdam

External identifiers

EU CT number

2023-506594-35-00

WHO UTN

U1111-1295-1698

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of one or more LNM compared to final pathology after TME, defined as sensitivity and specificity.
Group B: Rate of false-positive LNM on [68Ga]Ga-FAPI-46 PET/CT after local excision, defined as one or more suspected lymph nodes on [68Ga]Ga-FAPI-46 PET/CT that reveal no malignant cells on final histopathology after completion TME.

Secondary objectives 6

1. Per-lesion analysis of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of LNM compared to final pathology after TME.
2. Percentage of agreement between tumor uptake in the lymph nodes on the [68Ga]Ga-FAPI-46 PET/CT scan, histopathologic evidence of tumor in the lymph nodes, and the expression of FAP on immunohistochemistry (IHC).
3. Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
4. Difference in diagnostic accuracy for staging rectal cancer between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT versus regular CT and MRI).
5. Diagnostic incidence of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT.
6. Diagnostic accuracy of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT.

Conditions and MedDRA coding

Rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Group A: Patients aged ≥18 years with suspected or confirmed cT1-3N0-1M0 rectal cancer, defined as tumour invasion not extending beyond the perirectal tissue on standard MRI, with or without evidence of locoregional LNM on MRI, and no evidence of distant metastases on chest and abdominal CT.
2. Group A: Scheduled for primary TME (i.e. without prior local excision and without neo-adjuvant treatment).
3. Group A: Approval of the local multidisciplinary colorectal tumour board for performing primary TME.
4. Group B: Patients aged ≥18 years with high-risk rectal cancer, defined as the presence of at least one histological risk factors as described in the latest Dutch CRC guideline
5. Group B: Planned for completion TME following local excision
6. Group B: Approval of the local multidisciplinary colorectal tumour board for performing completion TME.

Exclusion criteria 3

1. Group A & B: Not able to communicate in Dutch or English
2. Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer)
3. Group A & B: Pregnant (either the patient or someone in the same household) or lactating women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Group A: Diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of 1 or more LNM compared to final pathology after TME, defined as sensitivity and specificity.
2. Group B: Rate of false-positive LNM on [68Ga]Ga-FAPI-46 PET/CT after local excision, defined as one or more suspected lymph nodes on [68Ga]Ga-FAPI-46 PET/CT that reveal no malignant cells on final histopathology after completion TME.

Secondary endpoints 6

1. Per-lesion analysis of the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT for the detection of LNM compared to final pathology after TME.
2. Percentage of agreement between tumor uptake in the lymph nodes on the [68Ga]Ga-FAPI-46 PET/CT scan, histopathologic evidence of tumor in the lymph nodes, and the expression of FAP on immunohistochemistry (IHC).
3. Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
4. Difference in diagnostic accuracy for staging rectal cancer between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT versus regular CT and MRI.
5. Diagnostic incidence of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT.
6. Diagnostic accuracy of incidental findings, unrelated to the diagnosed rectal cancer, on [68Ga]Ga-FAPI-46 PET/CT.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Dr. J.K. Wiggers

Public contact point

Organisation

Amsterdam UMC

Contact name

Dr. J.K. Wiggers

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications